[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,92,0,25,[9,42,65,90,116,140,163,191,226,259,282,304,327,360,388,417,447,474,495,524,552,573,601,625,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100509155","fih-study-of-the-geminus-tavi-system-in-patients-with-severe-symptomatic-aortic-stenosis-100509155",false,"NCT05909748","FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis","First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient understands the implications of participating in the study and provides informed consent\n3. Patient is willing to comply with specified follow-up evaluation\n4. Severe aortic stenosis as per ACC\u002FAHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2\u002Fm2)\\* AND PV ≥ 4 m\u002Fsec or mean gradient ≥ 40 mmHg)\\*\\* as determined by TTE\u002FCT-TAVI\n\n   \\*May be larger with mixed AS\u002FAR\n\n   \\*\\*For low flow low gradient AS or paradoxical low flow severe AS must meet ACC\u002FAHA guidelines (table 13 stages of AS in the guideline)\n5. Cardiac Symptoms: ≥ NYHA Class II\n6. Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.\n7. Aortic annulus diameter ≥22 mm and \\\u003C 29 mm, assessed by CT TAVI\n8. Anatomically suitable for implantation of the GEMINUS device\n9. Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter \\> 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.\n10. Patients assessed by the heart team to be at high risk for access site related bleeding\u002Fvascular complications due to the caliber\u002F calcification\u002F atherosclerosis of the iliofemoral vessels.\n\nExclusion Criteria:\n\n1. Patient not suitable for surgical bailout\n2. Congenital uni\u002Fbi\u002Fquadricuspid valve, or noncalcified aortic valve.\n3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).\n4. Active or recent (within 6 months) endocarditis.\n5. Active systemic infections.\n6. Recent MI (≤ 1 month).\n7. Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.\n8. Prosthetic heart valve in any position.\n9. Severe (\\> 3+) mitral, tricuspid or pulmonic regurgitation.\n10. Blood dyscrasias as defined: leukopenia (WBC\\\u003C3000\u002Fmm3), acute anemia (Hb \\\u003C8mg%), thrombocytopenia (platelet count \\\u003C50,000 cells\u002Fmm3), history of bleeding diathesis or coagulopathy.\n11. Untreated clinically significant coronary artery disease requiring revascularization.\n12. Hemodynamic instability requiring inotropic support or mechanical support devices.\n13. Hypertrophic cardiomyopathy with or without obstruction (HCM).\n14. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C20%.\n15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n16. Active peptic ulcer or upper GI bleeding within the prior 3 months.\n17. Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).\n18. Recent (\\\u003C6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).\n19. Renal insufficiency (eGFR\\\u003C30 mL\u002Fmin) and\u002For end stage renal disease requiring chronic dialysis.\n20. Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter \\> 5cm), marked tortuosity, or severe aortic arch atheroma.\n21. Life expectancy \\\u003C 12 months due to non-cardiac co-morbid conditions.\n22. Currently participating in an investigational drug or another device study that has not reached its primary endpoint","ALL","18 Years","120 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis.\n\nThis is a prospective, open label, multicentre, single arm, first in human clinical study.\n\nClinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation",[28],"Aortic Valve Stenosis","RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2023-05-21",{"date":37,"type":22},"2030-04",{"name":39,"class":40},"Valve Medical","INDUSTRY",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100505528","intravascular-lithotripsy-in-high-risk-calcified-iliac-anatomy-for-transfemoral-tavr-100505528","NCT05862558","Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR","ILIT","Inclusion Criteria:\n\n1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent\n2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).\n3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure\n4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.\n5. Subjects can provide written, informed consent.\n\nExclusion Criteria:\n\n1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.\n2. Subject who has contraindications to IVL\n3. Subject who has contraindications or is not eligible for TAVR","90 Years",{"count":51,"type":22},50,"OBSERVATIONAL","To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)",[55,28],"Iliac Disease",{"date":32,"type":33},{"date":58,"type":33},"2023-03-30",{"date":60,"type":22},"2027-10-01",{"name":62,"class":63},"Baylor Research Institute","OTHER",1,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":75,"studyType":52,"phases":4,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100555091","hydra-registry---uk-100555091","NCT06507579","Hydra Registry - UK","Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation\n2. Full understanding and willing to provide informed consent to study enrolment\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.","99 Years",{"count":74,"type":22},250,"1 Year","The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.\n\nThe study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.",[28],[79],"Aortic Valve Stenosis, TAVI, Hydra","2026-08-17",{"date":82,"type":33},"2026-08-18",{"date":84,"type":33},"2024-07-11",{"date":86,"type":22},"2027-08-01",{"name":88,"class":40},"Sahajanand Medical Technologies Limited",4,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100383674","landmark-trial-a-randomised-controlled-trial-of-myval-thv-100383674","NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.",{"count":99,"type":22},988,[25],"The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)",[28],[104,105,106],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series","2026-08-13",{"date":80,"type":33},{"date":110,"type":33},"2020-11-04",{"date":112,"type":22},"2033-12-31",{"name":114,"class":40},"Meril Life Sciences Pvt. Ltd.",54,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100558951","redo-transcatheter-aortic-valve-implantation-for-the-management-of-transcatheter-aortic-valve-failure-100558951","NCT06557798","REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure","Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve","REVALVE","Inclusion Criteria:\n\n1\\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing",{"count":125,"type":22},550,"Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.\n\nThe study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).\n\nThe study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.",[28],[129],"Bioprosthetic Valve Failure","2026-08-12",{"date":132,"type":33},"2026-08-14",{"date":134,"type":33},"2024-12-12",{"date":136,"type":22},"2033-03",{"name":138,"class":63},"The Leeds Teaching Hospitals NHS Trust",75,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":149,"studyType":52,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":41},"100636510","spanish-prospective-registry-of-hydra-thv-for-transcatheter-aortic-valve-implantation-100636510","NCT07566624","Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation","HYSPANIA","Inclusion Criteria:\n\nParticipants who meet ALL of the following conditions will be included:\n\n* Age ≥ 18 years and;\n* Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and\n* Signed informed consent.\n\nExclusion Criteria:\n\nPatients who do NOT meet ANY of the following conditions will be included:\n\n* Express refusal by the participant to participate in the study.\n* Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study.\n* Participants in randomised clinical trials who have not reached the research endpoint.\n* Pregnant and\u002For breastfeeding women.",{"count":148,"type":22},100,"12 Months","This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system.\n\nThe study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.",[152,153,28],"Severe Aortic Valve Stenosis","Valvular Heart Disease","2026-08-04",{"date":156,"type":33},"2026-08-05",{"date":158,"type":33},"2026-07-07",{"date":160,"type":22},"2029-02-01",{"name":162,"class":63},"Fundación EPIC",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":64},"100593628","cardioheartconnect-commercially-available-fitness-for-cardiac-rehabilitation-100593628","NCT07008911","CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation","CardioHeartConnect: Commercially Available Fitness mHealth for Cardiac Rehabilitation Among Individuals Recovering From Transcatheter Aortic Valve Replacement","Inclusion Criteria:\n\n* Appropriate for cardiac rehabilitation (CR) referral, as determined by the UCHealth Structural Heart \\& Valve Clinic team\n* Community-dwelling\n* Reside in the United States\n* Able to speak and understand English\n* Able to provide informed consent\n* Able to stand with or without an assistive device\n* Able to see and hear content on the Peloton App via phone, tablet, or computer\n\nExclusion Criteria:\n\n\\- Determined to be inappropriate for cardiac rehabilitation referral by the UCHealth Structural Heart and Valve Clinic team",{"count":171,"type":22},200,[25],"This trial evaluates the effectiveness of CardioHeartConnect, an eight-week mobile cardiac rehabilitation intervention using Peloton fitness modules, compared to educational control among patients recovering from transcatheter aortic valve replacement (TAVR). The study aims to improve physical activity, functional capacity, quality of life, and cardiovascular health using wearable devices and a digital engagement platform. A total of 200 patients will be recruited from the UCHealth Structural Heart and Valve Clinic and randomized to either CardioHeartConnect or CardioHeartEd. Participants will be assessed at baseline, 8 weeks, and 12 months using surveys, smartwatch data, and electronic health records.",[28,175],"Aortic Valve Disease",[177,178,179,180,181],"Cardiac Rehabilitation","Transcatheter Aortic Valve Replacement","TAVR","Mobile Health","Peloton","2026-07-31",{"date":184,"type":33},"2026-08-03",{"date":186,"type":33},"2025-08-29",{"date":188,"type":22},"2029-08-01",{"name":190,"class":63},"University of Colorado, Denver",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":64},"100650133","comparing-suture-vs-combined-closure-strategies-for-large-blood-vessel-access-in-patients-undergoing-transcatheter-aortic-valve-implantation-tavi-100650133","NCT07743697","Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)","SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI","SEAL-TAVI","Inclusion Criteria:\n\n* Patient is at least 18 years of age at the time of screening.\n* Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access.\n* Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team.\n* Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures.\n* Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations.\n\nExclusion Criteria:\n\n* Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian\u002Faxillary, or carotid access).\n* Emergency or non-elective TAVI procedure.\n* Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment.\n* Known active, unresolved local or systemic infection at the planned vascular access site.\n* Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide\u002FProStyle or Angio-Seal) that cannot be adequately premedicated.\n* Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy.\n* Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that could confound study endpoints.\n* Patient is pregnant or breastfeeding.\n* Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent).",{"count":200,"type":22},705,[25],"The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access).\n\nThe main questions it aims to answer are:\n\nDoes using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing?\n\nResearchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI.\n\nParticipants will:\n\nUndergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care.\n\nReceive an initial single-suture placement before the large TAVI delivery system is inserted.\n\nBe evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group).\n\nHave their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge.\n\nComplete a 72-hour safety and complication evaluation.",[28,204,205,206],"Postoperative Complications","Vascular System Injuries","Hemorrhage",[197,208,209,210,211,212,213,214,215,216,179,178],"Transcatheter Aortic Valve Implantation","TAVI","Vascular Closure Device","Suture-Based Closure","Angio-Seal","ProGlide","ProStyle","Large-Bore Access","Vascular Complications","NOT_YET_RECRUITING","2026-07-29",{"date":154,"type":33},{"date":221,"type":22},"2026-10-01",{"date":223,"type":22},"2028-09",{"name":225,"class":63},"University Hospital, Basel, Switzerland",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":64},"100461032","phase-4-single-antiplatelet-treatment-with-ticagrelor-or-aspirin-after-transcatheter-aortic-valve-implantation-100461032","NCT05283356","Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation","Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial","REAC-TAVI2","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures.\n2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.\n3. Patients with degenerative symptomatic severe aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:\n\n   1. Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol\u002Fl (126 mg\u002Fdl) or 2-h plasma glucose ≥ 11.1mmol\u002Fl (200mg\u002Fdl), or under treatment with an oral hypoglycemic or insulin.\n   2. Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.\n   3. Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study.\n4. Successful TAVI performed by any vascular access.\n5. Patients who are not participating in any other clinical trial or research study (registries allowed).\n\nExclusion Criteria:\n\n1. Patients under chronic oral anticoagulation for any specific pathology.\n2. Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.\n3. History of overt major bleeding or intracranial hemorrhage.\n4. Active pathological bleeding.\n5. History of ischemic stroke within the last 30 days prior TAVI.\n6. Patients with documented severe hepatic insufficiency.\n7. Known pregnancy, breast-feeding, or intend to become pregnant during the study period.\n8. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study.\n9. Patients randomized in another clinical trial with an investigational product or device over the past 30 days.\n10. Patients who cannot attend follow-up visits scheduled in the study.\n11. History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.",{"count":235,"type":22},1206,[237],"PHASE4","The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (\\\u003C1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts.\n\nThis is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.",[152,28,240,241],"Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Aortic Valve Implantation (TAVI)",[152,243,244,245,246,247,248,249],"Transcatheter aortic valve replacement (TAVR)","Transcatheter aortic valve implantation (TAVI)","Single antiplatelet therapy (SAPT)","Ticagrelor 60 mg","ASA 100 mg","Bleeding","Valve thrombosis","2026-07-27",{"date":252,"type":33},"2026-07-28",{"date":254,"type":33},"2022-01-21",{"date":256,"type":22},"2028-06-30",{"name":258,"class":63},"Fundacin Biomedica Galicia Sur",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100649417","a-prospective-multi-centre-single-arm-pivotal-clinical-study-to-determine-the-safety-and-effectiveness-of-crea-aortic-valve-for-use-as-a-replacement-aortic-heart-valve-100649417","NCT07734025","A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve","CREATE","Inclusion Criteria:\n\n* Age 60 years or older.\n* Symptomatic severe native calcific aortic valve stenosis.\n* Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.\n* Considered at high surgical risk for surgical aortic valve replacement.\n* Able to understand the study requirements and provide written informed consent.\n* Willing and able to comply with all study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Contraindication to transcatheter aortic valve replacement or the investigational procedure.\n* Active infection or endocarditis.\n* Life expectancy less than one year due to non-cardiac comorbidities.\n* Participation in another investigational study that could interfere with the objectives of this study.\n* Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.","60 Years","80 Years",{"count":21,"type":22},[25],"This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.\n\nThe study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.",[28,272],"Severe Aortic Stenosis",[178,179,208,28],"2026-07-24",{"date":218,"type":33},{"date":277,"type":22},"2026-12-04",{"date":279,"type":22},"2033-06-30",{"name":281,"class":40},"Onecrea Medical Inc.",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":64},"100575553","transcatheter-aortic-valve-implantation-comparison-of-the-effects-of-ultrasound-guided-pericapsular-nerve-group-block-and-fascia-iliaca-block-on-postoperative-analgesia-management-100575553","NCT06773780","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study","Inclusion Criteria:\n\n* Patients scheduled for TAVİ\n* aged between 18 and 85 years,\n* American Society of Anesthesiology (ASA) physical status II-IV\n\nExclusion Criteria:\n\n* History of bleeding diathesis.\n* Use of anticoagulant therapy.\n* History of chronic pain prior to surgery.\n* Multiple trauma.\n* Conditions where pain assessment cannot be performed (e.g., dementia).\n* Patients operated under spinal or epidural anesthesia.\n* Presence of infection in the region where the block will be applied.\n* Refusal to consent to the procedure","85 Years",{"count":291,"type":22},60,[25],"Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures.\n\nPatient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available.\n\nThe Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves.\n\nThis study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.",[28,208,295,296],"Pericapsular Nerve Group Block","Fascia Iliaca Block",{"date":250,"type":33},{"date":299,"type":33},"2025-01-10",{"date":301,"type":22},"2026-12-01",{"name":303,"class":63},"Medipol University",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100452551","alliance-aviv-safety-and-effectiveness-of-the-sapien-x4-transcatheter-heart-valve-in-failing-aortic-bioprosthetic-valves-100452551","NCT05172973","ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Inclusion Criteria:\n\n1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic valve size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Failing valve has moderate or severe paravalvular regurgitation\n3. Failing valve is unstable, rocking, or not structurally intact\n4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n5. Increased risk of THV embolization\n6. Surgical or transcatheter valve in the mitral position\n7. Severe mitral regurgitation (\\> 3+) or ≥ moderate mitral stenosis\n8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months\n9. Left ventricular ejection fraction \\\u003C 20%\n10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n11. Increased risk of coronary artery obstruction after THV implantation\n12. Myocardial infarction within 30 days prior to the study procedure\n13. Hypertrophic cardiomyopathy with subvalvular obstruction\n14. Subjects with planned concomitant ablation for atrial fibrillation\n15. Clinically significant coronary artery disease requiring revascularization\n16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n18. Endocarditis within 180 days prior to the study procedure\n19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n21. Renal insufficiency and\u002For renal replacement therapy\n22. Leukopenia, anemia, thrombocytopenia\n23. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n24. Hypercoagulable state or other condition that increases risk of thrombosis\n25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n26. Subject refuses blood products\n27. Body mass index \\> 50 kg\u002Fm2\n28. Estimated life expectancy \\\u003C 24 months\n29. Female who is pregnant or lactating\n30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n31. Participating in another investigational drug or device study that has not reached its primary endpoint\n32. Subject considered to be part of a vulnerable population",{"count":171,"type":22},[25],"The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4\u002FX4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.",[315,28],"Aortic Valve Insufficiency",[243,244,317,318],"SAPIEN X4\u002FX4S","Valve-in-valve",{"date":250,"type":33},{"date":321,"type":33},"2023-11-22",{"date":323,"type":22},"2039-12",{"name":325,"class":40},"Edwards Lifesciences",36,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":335,"maxAge":267,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":4},"100647814","phase-2-vericiguat-for-the-inhibition-of-calcific-aortic-valve-stenosis-progression-100647814","NCT07715279","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression","Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (VERIFICATION Study)","VERIFICATION","Inclusion Criteria:\n\n1. The participant agrees to enter this clinical trial and consents to long-term follow-up;\n2. 35 ≤ age \\\u003C 80 years;\n3. Echocardiographically confirmed mild-to-moderate (peak aortic jet velocity ≥ 2.5 m\u002Fs and \\\u003C 4.0 m\u002Fs, aortic valve area \\> 1.0 cm², and mean aortic valve pressure gradient \\\u003C 40 mmHg) non-rheumatic aortic valve stenosis;\n4. Baseline aortic valve calcium score (Agatston score) ≥ 200 AU as measured by cardiac CT;\n5. Male participants, or female participants who are not of childbearing potential, or female participants who commit to avoiding pregnancy through 4 weeks after the end of the trial.\n\nExclusion Criteria:\n\n1. Severe aortic stenosis (AS peak velocity ≥ 4.0 m\u002Fs, or mean transvalvular aortic pressure gradient ≥ 40 mmHg, or aortic valve area ≤ 1.0 cm², or indexed effective aortic valve area \\\u003C 0.6 cm²\u002Fm²), or very mild stenosis (AS peak velocity \\\u003C 2.5 m\u002Fs), or a planned aortic valvuloplasty\u002Freplacement procedure;\n2. Concomitant severe mitral or tricuspid valve disease (moderate or greater mitral or tricuspid regurgitation, or prior mitral or tricuspid valve repair\u002Fvalvuloplasty\u002Freplacement);\n3. Concomitant moderate or greater aortic regurgitation;\n4. Use, within 1 month prior to the screening visit, of medications affecting the NO-sGC-cGMP pathway (e.g., sildenafil, nitrates, etc.), or known hypersensitivity to vericiguat or its components;\n5. Left ventricular ejection fraction (LVEF) \\\u003C 50%, or NYHA class III-IV (see Appendix 4 for NYHA classification criteria);\n6. Presence of a malignancy (except those with an expected cure) or other serious non-cardiac disease with a life expectancy of less than 3 years;\n7. Rheumatic valvular heart disease;\n8. Systolic blood pressure (SBP) \\\u003C 120 mmHg, or a history of symptomatic hypotension, or a history of hemodynamic instability or hypovolemia within the 4 weeks prior to screening;\n9. Presence of hypertrophic obstructive cardiomyopathy (outflow tract obstruction defined as a peak left ventricular outflow tract pressure gradient ≥ 30 mmHg at rest or after provocative testing);\n10. Infective endocarditis or complex congenital heart disease;\n11. Estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin\u002F1.73 m², or on dialysis;\n12. Severe pulmonary disease requiring continuous home oxygen therapy;\n13. Interstitial lung disease;\n14. Concomitant disorder of calcium-phosphate metabolism;\n15. Current use of warfarin;\n16. ALT and AST ≥ 3 times the upper limit of normal, or severe hepatic insufficiency (e.g., cirrhosis, chronic active liver disease);\n17. Inability to undergo contrast-enhanced CT, or contrast media allergy;\n18. Concomitant acute myocarditis, cardiac amyloidosis, cardiac sarcoidosis, or stress (takotsubo) cardiomyopathy;\n19. Presence of acute coronary syndrome (including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction) within 60 days prior to randomization, or an indication for coronary revascularization (percutaneous intervention\u002Fbypass surgery); or a need for coronary revascularization identified at the time of randomization;\n20. History of cerebrovascular accident (including TIA or stroke) within 60 days prior to randomization;\n21. Psychiatric disorder or legal incapacity precluding the ability to provide informed consent;\n22. Any medical condition, circumstance, or history that, in the investigator's judgment, would compromise the participant's ability to participate in or complete the study.","35 Years",{"count":337,"type":22},238,[339],"PHASE2","Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS.\n\nThe primary questions this study aims to answer are:\n\nDoes vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo?\n\nThe study will compare vericiguat against a placebo (an inactive pill that is identical in appearance but contains no active drug). Both participants and the research team will not know which treatment each participant is receiving throughout the study.\n\nParticipants will:\n\nTake vericiguat or placebo orally once daily for 24 months; Begin treatment at 2.5 mg\u002Fday and undergo a stepwise dose increase every two weeks to a target dose of 10 mg\u002Fday, provided the drug is tolerated; Attend approximately 8 scheduled study visits over two years, during which they will undergo cardiac imaging examinations (transthoracic echocardiography and non-contrast cardiac CT), blood sample collection, physical assessment, and completion of standardized questionnaires on quality of life and heart failure symptoms; Undergo cardiac magnetic resonance imaging (MRI) at the beginning and end of the study, if there are no contraindications.\n\nApproximately 238 participants will be enrolled across roughly 19 hospitals in China.",[342,343,28],"Calcific Aortic Valve Disease","AORTIC VALVE DISEASES",[345,346,347,348,349,350],"Vericiguat","BAY1021189","Soluble Guanylyl Cyclase","sGC stimulator","sGC activator","Cyclic GMP","2026-07-18",{"date":353,"type":33},"2026-07-21",{"date":355,"type":22},"2026-08-20",{"date":357,"type":22},"2029-11-30",{"name":359,"class":63},"West China Hospital",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":64},"100647738","chateau-registry-clinical-outcomes-after-transcatheter-aortic-valve-replacement-100647738","NCT07709858","CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement","Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry","CHATEAU","Inclusion Criteria:\n\n* Adults (≥18 years of age).\n* Patients who underwent transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers.\n* TAVR performed between January 1, 2021 and December 31, 2025.\n* Availability of baseline procedural and follow-up clinical data in the institutional registry or medical records.\n\nExclusion Criteria:\n\n* Patients with insufficient clinical or procedural data for outcome assessment.",{"count":369,"type":22},4000,"This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025. The purpose of the study is to assess clinical outcomes and valve performance after TAVR in real-world practice, with a focus on procedural strategies, valve-related factors, and long-term outcomes. Patient clinical information, imaging findings, procedural data, echocardiographic results, and follow-up outcomes will be collected from existing medical records. No additional intervention, treatment, or study-specific visit will be performed.",[28,240],[373,178,179,374,375,376,377,378],"CHATEAU Registry","Aortic Stenosis","Real-world Data","Valve Performance","Clinical Outcomes","Multicenter Registry","2026-07-12",{"date":381,"type":33},"2026-07-17",{"date":383,"type":33},"2021-01-01",{"date":385,"type":22},"2027-12-31",{"name":387,"class":63},"Eunpyeong St. Mary's Hospital",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":396,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":403,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100490954","phase-4-enavogliflozin-outcome-trial-in-patients-with-severe-aortic-stenosis-after-transcatheter-aortic-valve-replacement-100490954","NCT05672836","ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement","A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients With Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and With Heart Failure With Preserved Ejection Fraction (HFpEF)","ENAVO-TAVR","Inclusion Criteria:\n\n1\\. Patients aged ≥19 with symptomatic aortic stenosis who underwent successful transcatheter aortic valve replacement (TAVR)\\* (either native valve or valve in valve with any approved\u002Fmarketed device).\n\n\\* A successful TAVI is defined as device success according to the VARC-2(Valve Academic Research Consortium 2) and VARC-3 criteria:\n\n1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND\n2. intended performance of the prosthetic heart valve (mean aortic valve gradient \\\u003C20 mmHg, peak velocity \\\u003C3 m\u002Fs, no moderate or severe prosthetic valve regurgitation) AND\n3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure).\n\n2\\. Heart Failure with Mildly Reduced or Preserved Ejection Fraction\n\n1. Left ventricular ejection fraction (LVEF) ≥40%\n2. structural heart disease\\_Left ventricular hypertrophy (LVH) or Left atrial enlargement\n\n   A. Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥ 1.1 cm or\n\n   B. Left atrial (LA) enlargement with at least one of the following: LA width (diameter) ≥3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20cm2, or LA volume ≥ 55mL or LA volume index ≥ 29mL\u002Fm.\n3. NT-proBNP ≥ 300 pg\u002FmL (for patients without ongoing atrial fibrillation) or NT-proBNP must be ≥ 600 pg\u002FmL (for patients with ongoing atrial fibrillation).\n\n3\\. Patients who voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support, or hemodynamic instability following the transcatheter aortic valve replacement procedure.\n2. Currently receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization; discontinuation of current use of SGLT2 inhibitor for the purposes of study enrolment is not permitted.\n3. Known allergy, hypersensitivity, or previous intolerance to an SGLT2 inhibitors.\n4. HF with reduced ejection fraction (LVEF \\\u003C40%).\n5. Type 1 diabetes mellitus or diabetes ketoacidosis.\n6. Chronic cystitis and\u002For recurrent urinary tract infection (≥2 times within 1 year).\n7. Stroke or transient ischemic attack within 12 weeks prior to enrollment.\n8. Symptomatic persistent hypotension and\u002For a systolic blood pressure (SBP) \\\u003C 95 mm Hg at screening or at randomization.\n9. SBP ≥180 mmHg irrespective of treatment or SBP ≥160 mmHg with at least ≥3 antihypertensive drugs at screening or randomization.\n10. Heart failure due to any of the following causes; known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis, haemochromatosis, Fabry disease), active myocarditis, constrictive pericarditis, cardiac tamponade, known hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy\u002Fdysplasia (ARVD), or uncorrected primary valvular disease.\n11. Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 of body-surface area based on the Modification of Diet in Renal Disease (MDRD) formula) or end-stage renal disease or requiring dialysis at the time of screening.\n12. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices, coagulopathy) or serum levels of transminases or alkaline phosphatase more than two times the upper limit of normal at screening.\n13. Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension.\n14. Current or suspicious malignancy or history of malignancy within 5 years\n15. Uncontrolled anaemia or haemoglobin \\\u003C9g\u002Fdl\n16. Uncontrolled hypothyroidism or arrhythmia or tachycardia\n17. Current ongoing alcoholic or drug addict\n18. Subjects with non-cardiac co-morbidities with life expectancy less than 12 months\n19. Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)\n20. Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.\n21. Participation in other clinical trials, However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;\n\n    * Participating in the observational study expected no effect on the safety and\u002For effectiveness evaluation of this trial.\n    * Screening failed before any interventional factor is involved.\n    * Participants who have completed their involvement in clinical trials and have surpassed a 4-week period since their last administration of the investigational drug.\n    * Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.","19 Years",{"count":398,"type":22},1040,[237],"The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.",[28,402],"Heart Failure",[208,404,405,406],"heart failure with preserved ejection fraction","Sodium-glucose cotransporter-2 inhibitor","transcatheter aortic valve replacement","2026-06-26",{"date":409,"type":33},"2026-06-29",{"date":411,"type":33},"2024-12-18",{"date":413,"type":22},"2029-04",{"name":415,"class":63},"Duk-Woo Park, MD",31,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":424,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100614216","capture-2-controlled-arterial-protection-to-ultimately-remove-embolic-material-100614216","NCT07276711","CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material","Controlled Arterial Protection to Ultimately Remove Embolic Material","Clinical Inclusion Criteria\n\n1. Age ≥ 22 years at the time of consent\n2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.\n3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram\n4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures\n5. Willing and able to comply with the protocol-specified procedures and assessments\n\nImaging Inclusion Criteria\n\n1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.\n2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:\n\nEmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:\n\n* Ascending aorta length ≥8 cm\n* Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm\n* Ascending aorta\u002Faortic arch diameter is ≥25 or ≤40 mm.\n* Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification\n\nSentinel Angiographic (CTA) Inclusion Criteria\n\n1\\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:\n\n* Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery\n* Arterial stenosis \\\u003C70% in either the left common carotid artery or the brachiocephalic artery\n* Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium\n* Adequate blood flow to the right upper extremity\n* Access vessels without excessive tortuosity\n\nExclusion Criteria:\n\n1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure\n2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \\[NIHSS\\] \\>1 at baseline)\n3. Left ventricular ejection fraction \\\u003C30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure\n4. Acute myocardial infarction (MI) within 30 days of the planned index procedure\n5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.\n6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin\n8. History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated\n9. Undergoing therapeutic thrombolysis\n10. History of bleeding diathesis or major coagulopathy\n11. Hepatic failure (Child-Pugh class C)\n12. Active endocarditis or ongoing systemic infection, defined as fever (\\>38°C) and\u002For WBC \\>15,000 IU\n13. Known allergy to any materials used in the EmStop system (e.g., nitinol)\n14. Currently participating in another drug or device clinical study\n15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure\n16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study","22 Years",{"count":426,"type":22},663,[25],"The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus\u002Fdebris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.",[28,374,175],[243,431,432,433,434,435,436,437],"Cerebral embolic protection device","Stroke","Cerebrovascular accident","Neuroprotection","Aortic valve disease","Aortic valve stenosis","Aortic stenosis","2026-06-24",{"date":407,"type":33},{"date":441,"type":33},"2026-05-12",{"date":443,"type":22},"2028-05",{"name":445,"class":40},"EmStop Inc",3,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},"100519907","comparison-of-allegra-vs-sapien-transcatheter-aortic-valves-in-valve-in-valve-indication-100519907","NCT06049654","Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Inclusion Criteria:\n\nPatients meeting ALL the following criteria will be included:\n\n* Patients aged ≥ 18 years.\n* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \\\u003C 1.0 cm2) and\u002For severe valve regurgitation.\n* The patient has cardiac symptoms and\u002For deterioration of left ventricular ejection fraction attributable to the aortic valve disease.\n* Heart team decision of VIV procedure.\n* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.\n\nExclusion Criteria:\n\nPatients meeting, at least, 1 of the following criteria will be excluded:\n\n* Patients who openly express their refusal to participate in the study.\n* Female patients in gestational age.\n* Presence or suspicious of biological aortic valve thrombosis.\n* Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.\n* Ongoing sepsis and\u002For suspicious or diagnosis of endocarditis.\n* Patients whose life expectancy is \\\u003C 1 year due to non-cardiac comorbid conditions.\n* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.\n* True inner diameter of the prosthetic valve \\> 27 mm.\n* Transfemoral access inadequate to accommodate an 18F sheath.\n* Patients included in other clinical trials (excluding registries).",{"count":455,"type":22},104,[25],"The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.",[28,459],"Structural Valve Deterioration",[461,437,462,463,464],"Valve-In-Valve","Aortic regurgitation","Trans-catheter aortic valve","Degenerated aortic valve","2026-06-12",{"date":467,"type":33},"2026-06-15",{"date":469,"type":33},"2024-02-01",{"date":471,"type":22},"2027-11-01",{"name":162,"class":63},11,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":64},"100462992","phase-2-impact-of-local-tissue-inflammation-on-intramyocardial-conduction-pathways-post-percutaneous-valve--evaluation-by-positron-emission-tomography-on-exploratory-cohort-100462992","NCT05308888","Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort","IMPACT","Inclusion Criteria:\n\n* Major patient (\\>18 years of age);\n* Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2\u002Fm2 body surface area), OR transvalvular peak velocity ≥ 4 m\u002Fs OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;\n* Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction \\\u003C 50% ;\n* Patient with vascular anatomy compatible with percutaneous femoral valve implantation;\n* Patient affiliated to or benefiting from a health insurance plan;\n* Patient who has provided free, informed and written consent.\n\nExclusion Criteria:\n\n* Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;\n* Patient with a uni or bicuspid aortic valve;\n* Patient with severe left ventricular dysfunction LVEF \\\u003C 30%;\n* Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;\n* Patient with iliofemoral vascular anatomy preventing safe passage of the valve;\n* Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position;\n* Inability or refusal to consent;\n* Pregnant or breastfeeding woman;\n* Patient under judicial protection or family habilitation;\n* Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship;\n* Patient with life expectancy \\\u003C 12 months.",{"count":148,"type":22},[339],"Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines.\n\nThis technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve.\n\nTAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%.\n\nPacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization.\n\nNot all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation.\n\nIn view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation.\n\nThe purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.",[28],[209],"2026-06-08",{"date":488,"type":33},"2026-06-09",{"date":490,"type":33},"2022-11-23",{"date":492,"type":22},"2028-11-23",{"name":494,"class":63},"University Hospital, Brest",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":505,"studyType":52,"phases":4,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":64},"100637453","impact-of-trans-catheter-aortic-valve-implantation-on-renal-function-100637453","NCT07626710","Impact of Trans-catheter Aortic Valve Implantation on Renal Function","Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry","TAVIKOD","Inclusion Criteria:\n\n* Age \\>18 years with a life expectancy \\>1 year;\n* Patient candidate for percutaneous aortic valve implantation after formal indication of our \"Heart Team\".\n* Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months.\n* Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days.\n* Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date).\n\nExclusion Criteria:\n\n* Female with childbearing potential or lactating;\n* Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2);\n* Candidate for dialysis treatment;\n* Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year;\n* Absent or incomplete renal function assessment after each contrast-based procedure;\n* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;",{"count":504,"type":22},1000,"5 Years","Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown.\n\nThis registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution",[28,508,509],"Chronic Kidney Diseases","Renal Failure Acute Chronic",[511,512,513,514],"Trans-catheter aortic valve implantation","Contrast-induced acute renal injury","Kidney failure","Observational registry","2026-05-31",{"date":517,"type":33},"2026-06-04",{"date":519,"type":33},"2024-08-30",{"date":521,"type":22},"2033-08-30",{"name":523,"class":63},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":533,"conditions":534,"keywords":538,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100639710","prospective-neuropsychological-evaluation-of-the-implementation-of-a-heart-valve-unit-hvu-neuro-100639710","NCT07626567","Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)","HVU-NEURO","Inclusion Criteria:\n\n* Severe aortic valve stenosis\n* Indication for transcatheter valve therapy according to current guideline recommendations and\u002For Heart-Team consensus\n* Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German\n* Age ≥18 years\n* Willingness to participate voluntarily with written informed consent\n\nExclusion Criteria:\n\n* Known pregnancy at the time of study inclusion\n* Life expectancy \\\u003C1 year due to non-cardiac disease\n* Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \\[TIA\\], migraine, epilepsy) with acute symptoms that may interfere with data collection",{"count":532,"type":22},500,"Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.\n\nHeart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.\n\nHVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.\n\nNeurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.",[28,535,536,537],"Postoperative Cognitive Dysfunction (POCD)","Delirium - Postoperative","Neurocognitive Disorders",[209,539,540,541,542,208,543],"HVU","Postoperative Cognitive Decline","Postoperative Delirium","Neuropsychology","Intensive Care Delirium Screening Checklist","2026-05-29",{"date":517,"type":33},{"date":547,"type":22},"2026-05-25",{"date":549,"type":22},"2028-02",{"name":551,"class":63},"Heart and Brain Research Group, Germany",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":559,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":64},"100614819","smartphone-based-digital-screening-for-aortic-valve-stenosis-100614819","NCT07284550","Smartphone Based Digital Screening for Aortic Valve Stenosis","SMART-VALVE","The following inclusion and exclusion criteria will be used for training, validation and test sets:\n\nInclusion criteria for group I (moderate to severe AS):\n\n* Moderate to severe AS defined as AVA ≤ 1.5cm² in echocardiographic assessment\n* No other significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nInclusion criteria for group II:\n\n* No significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nExclusion criteria (applicable for all groups):\n\n• Informed consent form not signed.",true,{"count":532,"type":22},"Heart valve diseases are among the most serious cardiovascular conditions in older age. One of the most common forms is aortic valve stenosis, a narrowing of the valve opening between the left ventricle and the main artery. As the valve becomes tighter, the heart must work harder and harder to pump blood through the body. This process often develops slowly over many years and initially causes no clear symptoms. As a result, the condition is frequently detected only in advanced stages, when warning signs such as shortness of breath, chest pain, or dizziness appear. Without treatment, aortic valve stenosis can become life-threatening. If detected early, however, very effective treatment options are available today.\n\nUp to now, the disease has been reliably diagnosed mainly through echocardiography. Yet this method is complex, costly, and requires specialized medical staff. A simple, affordable, and broadly accessible screening option does not yet exist.\n\nThe interdisciplinary clinical research project explores whether conventional smartphones could fill this gap. Almost all modern devices are equipped with sensors such as microphones, accelerometers, and gyroscopes. These can capture both heart sounds and subtle vibrations of the chest. The research team is investigating whether reliable diagnostic information for the diagnosis of aortic valve stenosis can be extracted from such recordings. To achieve this, the signals are processed with newly developed methods and analyzed using artificial intelligence.\n\nFor the study, several hundred patients with and without valve disease will be examined. The smartphone results will be compared with established diagnostic standards, particularly echocardiography, to test accuracy and reliability.\n\nIf successful, the approach could enable a straightforward, digital heart check at home using nothing more than a conventional smartphone. Such a tool would provide an accessible, low-cost, and widely available method for early detection, helping more people receive timely and potentially life-saving treatment.",[28,563],"Artifical Intelligence","2026-05-27",{"date":566,"type":33},"2026-05-28",{"date":568,"type":33},"2026-01-12",{"date":570,"type":22},"2029-11",{"name":572,"class":63},"Medical University Innsbruck",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100341627","von-willebrand-factor-point-of-care-testing-to-improve-minimally-invasive-tavi-outcomes-100341627","NCT03728049","Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes","Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI","WITAVI-REAL","Inclusion Criteria:\n\n* All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.\n* Symptomatic aortic stenosis scheduled to undergo TAVI\n* TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia\u002Fconscious sedation; no TEE guidance.\n* All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted\n\nExclusion Criteria:\n\n* TAVI through non-transfemoral approach\n* TAVI with concomitant percutaneous coronary intervention\n* TAVI performed under general anesthesia\n* TAVI performed under TEE guidance\n* Valve-in-valve procedure\n* Inability to provide informed consent\n* Associated ≥ moderate mitral regurgitation\n* Peri-procedural treatment with ticagrelor or prasugrel treatment \u002F direct oral anticoagulant",{"count":582,"type":22},944,[25],"Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.\n\nThe hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).",[28,315],[178,587,588,589,437,590],"Paravalvular regurgitation","Point-of-care test","Biomarker","Von willebrand Factor","2026-05-20",{"date":593,"type":33},"2026-05-22",{"date":595,"type":33},"2019-12-18",{"date":597,"type":22},"2026-12",{"name":599,"class":63},"University Hospital, Lille",9,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":89},"100497547","the-effect-of-subclinical-leaflet-thrombosis-and-prosthesis-type-on-transcatheter-aortic-valve-degeneration-popular-pet-tavi-100497547","NCT05758662","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration","Inclusion Criteria:\n\n* Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago\n* Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Temporary or chronic oral anticoagulation use after TAVI\n* Known severe renal insufficiency\n* Known severe paravalvular regurgitation\n* History of valve-in-valve procedure\n* History of aortic valve re-intervention (including percutaneous paravalvular leak closure)",{"count":609,"type":22},180,"A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.",[28],[209,179,613,614,615,616],"Subclinical Leaflet Thrombosis","Bioprosthetic Valve Deterioration","Intra-annular","Supra-annular","2026-05-18",{"date":619,"type":33},"2026-05-19",{"date":621,"type":33},"2023-11-16",{"date":221,"type":22},{"name":624,"class":63},"St. Antonius Hospital",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":633,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":652,"locationsCount":64},"100493901","structured-shared-decision-making-for-patients-undergoing-savr-or-tavr-100493901","NCT05711186","Structured Shared Decision Making for Patients Undergoing SAVR or TAVR","Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial","TOGETHER","Inclusion Criteria:\n\n1. Age ≥ 70 years\n2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \\\u003C0.6cm2\u002Fm2\n3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year irrespective of valvular heart disease\n2. Inability to provide informed consent\n3. Participation in another clinical trial with an active intervention","70 Years",{"count":635,"type":22},140,[25],"Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.\n\nThe objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.\n\nTOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.",[28,639],"Symptomatic Aortic Stenosis",[639,28,641,642,643,644,645],"SAVR (Surgical Aortic Valve Replacement)","Shared Decision-Making","TAVR (Transcatheter Aortic Valve Replacement)","TAVI (Transcatheter Aortic Valve Implantation)","Decision Support Techniques","2026-05-07",{"date":648,"type":33},"2026-05-08",{"date":650,"type":33},"2023-04-17",{"date":385,"type":22},{"name":653,"class":63},"Insel Gruppe AG, University Hospital Bern",{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":660,"targetDuration":4,"studyType":23,"phases":662,"briefSummary":663,"conditions":664,"keywords":665,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":64},"100635733","phase-4-patient-quality-of-recovery-after-tavr-with-different-sedation-regimens-100635733","NCT07556523","Patient Quality of Recovery After TAVR With Different Sedation Regimens","Inclusion Criteria:\n\n* 18-90 years old, inclusive\n* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)\n* Speaks English or Spanish\n* Consents to participate\n\nExclusion Criteria:\n\n* Preoperative heart rate \\\u003C 50 bpm or arrhythmias (e.g., AFib with RVR)\n* Conduction abnormalities (e.g., 2nd\u002F3rd degree AV block without pacer)\n* Allergy or contraindication to study drugs\n* Pulmonary artery pressure \\> 70mmHg\n* Morbid obesity BMI \\> 50\n* Pregnancy\n* Unable to consent in English or Spanish",{"count":661,"type":22},126,[237],"The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.\n\nResearchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.\n\nParticipants will:\n\n* Be enrolled before their scheduled TAVR procedure\n* Be randomly assigned to receive one of the three sedation medications during their procedure\n* Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience",[240,28],[666,179,667,668],"Transcatheter aortic valve replacement","Sedation strategy","Anesthesia","2026-04-22",{"date":671,"type":33},"2026-04-29",{"date":673,"type":33},"2026-03-16",{"date":675,"type":22},"2028-06",{"name":677,"class":63},"David Lyubashevsky"]