[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcatheter-aortic-valve-implantation-tavi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcatheter-aortic-valve-implantation-tavi":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,85,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100461032","phase-4-single-antiplatelet-treatment-with-ticagrelor-or-aspirin-after-transcatheter-aortic-valve-implantation-100461032",false,"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.","ALL","18 Years",{"count":20,"type":21},1206,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Severe Aortic Valve Stenosis","Aortic Valve Stenosis","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Aortic Valve Implantation (TAVI)",[27,32,33,34,35,36,37,38],"Transcatheter aortic valve replacement (TAVR)","Transcatheter aortic valve implantation (TAVI)","Single antiplatelet therapy (SAPT)","Ticagrelor 60 mg","ASA 100 mg","Bleeding","Valve thrombosis","RECRUITING","2026-07-27",{"date":42,"type":43},"2026-07-28","ACTUAL",{"date":45,"type":43},"2022-01-21",{"date":47,"type":21},"2028-06-30",{"name":49,"class":50},"Fundacin Biomedica Galicia Sur","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284","NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.",{"count":61,"type":21},300,"OBSERVATIONAL","Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[65,66,67,30],"Aortic Stenosis","Mitral Regurgitation","Tricuspid Regurgitation",[69,33,70,71,72,73,74],"Aortic stenosis","Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","NOT_YET_RECRUITING","2026-05-28",{"date":78,"type":43},"2026-06-03",{"date":80,"type":21},"2026-06-05",{"date":82,"type":21},"2034-06-05",{"name":84,"class":50},"Josep Rodes-Cabau",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":51},"100629034","preliminary-exploration-of-factors-affecting-complete-hemostasis-and-supine-time-after-removal-of-femoral-arterial-sheath-in-icu-patients-100629034","NCT07469397","Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients","Inclusion Criteria:\n\n1. Patients admitted to the cardiac intensive care unit of this hospital.\n2. Patients undergoing femoral arterial sheath removal.\n3. Age 20 years or older.\n\nExclusion Criteria:\n\n1. Patients unable to maintain supine position or refusing physical restraints.\n2. Patients with severe hematoma, vascular rupture, or other vascular complications present at the femoral arterial puncture site at the time of sheath insertion.\n3. Patients with a diagnosis of severe disseminated intravascular coagulation (DIC).","20 Years",{"count":93,"type":21},157,"Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used. Patients must lie supine for at least 6 hours, often experiencing discomfort including back pain, eating difficulties, and urinary problems. The compressed leg is restrained to prevent movement, adding to the discomfort. Despite adhering to this standard procedure, some patients still develop bleeding or hematomas after compression, requiring extended treatment. Current research on predicting compression duration and bleeding risk factors after femoral arterial sheath removal is limited and inconsistent. This study aims to identify factors that can more accurately predict necessary compression time after initial hemostasis, potentially reducing patient discomfort and complications such as prolonged bleeding, extended compression, and hematoma formation, which can impact vital signs.\n\nPurpose:To understand the factors influencing complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients.\n\nMethods:Clinical data were collected through observation, and statistical analysis was performed using SPSS.\n\nExpected Outcomes:To identify factors that influence complete hemostasis and supine duration after femoral arterial sheath removal in ICU patients, and to develop a prediction model that allows clinical units to accurately assess the required supine compression time following femoral arterial sheath removal.",[96,97,98,99,30],"Removal of Femoral Arterial Sheath in ICU Patients","Complete Hemostasis","Coronary Artery Disease","Percutaneous Coronary Intervention",[97,101],"Supine Time","2026-03-10",{"date":104,"type":43},"2026-03-13",{"date":106,"type":43},"2025-05-15",{"date":108,"type":21},"2026-12-31",{"name":110,"class":50},"National Taiwan University Hospital",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":51},"100590050","clinical-feasibility-and-evaluation-study-of-point-guard-embolic-protection-device-during-tavr-guardian-100590050","NCT06962371","Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)","GUARDIAN Australian Feasibility Study: Safety and Feasibility","GUARDIAN","Inclusion Criteria:\n\n1. The patient is ≥18 years of age;\n2. The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);\n3. The patient is willing to comply with protocol-specified follow-up evaluations;\n4. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.\n\nExclusion Criteria:\n\n1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).\n2. Anatomy that precludes safe delivery and retrieval of the investigational device.\n3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.\n4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.\n5. Patients with uncontrolled bleeding disorders.\n6. Patients who are pregnant, as confirmed by a positive pregnancy test.\n\nGeneral Exclusion Criteria\n\n1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).\n2. Anatomy that precludes safe delivery and retrieval of the investigational device.\n3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.\n4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.\n5. Patients with uncontrolled bleeding disorders.\n\n5\\. Patients who are pregnant, as confirmed by a positive pregnancy test.\n\nMagnetic resonance imaging exclusion criteria:\n\n1. Body Mass Index (BMI) and\u002For total body weight precluding imaging in scanner.\n2. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).\n3. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).\n4. Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.\n5. Claustrophobia precluding MRI scanning.",{"count":120,"type":21},30,[122],"NA","The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.",[30,28,125],"Transcatheter Aortic Valve Replacement",[127,128,129,130,131,132],"CEP","Cerebral Embolic Protection","CEP Device","TAVR","TAVI","stroke","2025-04-29",{"date":135,"type":43},"2025-05-08",{"date":137,"type":43},"2025-04-07",{"date":139,"type":21},"2026-03",{"name":141,"class":142},"Transverse Medical, Inc.","INDUSTRY"]