[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-regurgitation":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,59,90,124,147,170,191,221,257,277,306,336,358,388,410,430,450,474,494,516,553,575,599,620,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100650944","importance-of-point-of-care-ultrasound-for-early-detection-of-valvular-and-cardiac-diseases-improve-100650944",false,"NCT07756398","Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)","IMPROVE","Inclusion Criteria:\n\nProvider (cluster) participants:\n\n* Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients\n* Patient panel comprising \\>50% adults aged 65 years or older\n* Sees patients in ambulatory clinic at least 1 day per week on average\n* Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel\n* Provides written informed consent\n\nPatient participants:\n\n* Adults aged 65 to 85 years, inclusive\n* Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic\n* Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram\n\nExclusion Criteria:\n\nProvider (cluster) participants:\n\n* Serving in a locum tenens or other temporary capacity\n* Unwilling or unable to nominate an AI-POCUS champion from the clinic\n\nPatient participants:\n\n* Echocardiogram performed within the past 5 years\n* At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram\n* History of surgical or transcatheter intervention for aortic or mitral valve disease\n* Self-reported structural heart disease\n* Significant frailty burden or comorbidities limiting life expectancy to\n\n  1 year or less\n* Unable to provide informed consent","ALL","65 Years","85 Years",{"count":21,"type":22},1088,"ESTIMATED","INTERVENTIONAL",[25],"NA","Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.\n\nThis study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.\n\nPrimary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.",[28,29,30,31],"Valvular Heart Disease Patients","Aortic Stenosis","Mitral Regurgitation","Left Ventricular Diastolic Dysfunction",[33,34,35,36,37,38,39,40,41,42,43,44,45],"Point-of-care ultrasound","POCUS","Artificial Intelligence","AI-guided imaging","Echocardiography","Screening","Early detection","Heart Failure","Older Adults","Geriatrics","Primary Care","Cluster randomized Trial","Implementation Science","NOT_YET_RECRUITING","2026-08-12",{"date":49,"type":50},"2026-08-17","ACTUAL",{"date":52,"type":22},"2026-08-01",{"date":54,"type":22},"2028-12-01",{"name":56,"class":57},"University of Texas Southwestern Medical Center","OTHER",2,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100603013","reduction-or-elimination-of-mitral-regurgitation-with-the-saturn-tmvr-system-cassini-us-100603013","NCT07130994","Reduction or Elimination of Mitral Regurgitation With the SATURN TMVR System (CASSINI-US)","Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-septal TMVR System in Patients With Severe, Symptomatic Mitral Regurgitation (Cassini-US)","CASSINI-US","Inclusion Criteria:\n\n* Age 18 years or older.\n* Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+).\n* NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.\n* Ability to tolerate oral anticoagulation.\n* Ability to qualify for bailout surgery (which may include open heart surgery).\n* High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.\n* Willing and able to complete study-related assessments and questionnaires.\n\nExclusion Criteria:\n\n* Purely degenerative (organic\u002Fprimary) (i.e. intrinsic valve lesions) mitral regurgitation.\n* Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement.\n* Life expectancy \\\u003C1 yr. due to noncardiac conditions.\n* Endocarditis in the 3 months prior to procedure date.\n* Current admission with acute heart failure exacerbation.\n* Dependency on inotropic agents or mechanical circulatory support.\n* Untreated clinically significant CAD.\n* Active systemic infection.\n* Modified Rankin Scale ≥4 disability.\n* Chronic renal failure defined as eGFR \\\u003C 30 mL\u002Fmin\u002Fm2 or on renal replacement therapy.\n* Severe pulmonary arterial hypertension (PAH), defined as PASP \\> 70mmHg.\n* Platelets \\\u003C 90,000.\n* COPD on home oxygen therapy deemed too high risk for intubation.\n* Refuses blood transfusions.\n* Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).\n* Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.\n* Participating in other investigational studies likely to confound the results or affect the study.\n* Unable or does not sign the study informed consent form.\n* Patients classified as \"vulnerable patients\"\n\nCardiovascular Exclusion Criteria\n\n* Myocardial infarction during prior 30 days.\n* Stroke or TIA during prior 90 days.\n* Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).\n* Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.), and\u002For anticipated mitral valve treatment prior to enrollment.\n* Prior surgical mechanical valve AVR.\n* Prior TAVI. -Need for any planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure.\n* CRT, CRT-D, IPG or ICD implanted in previous 30 days.\n* Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure \\\u003C90mmHg, Inotropic dependent or IABP\u002Fmechanical circulatory support.\n\nCABG or PCI within previous 30 days.\n\n* Inadequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure, as reviewed by the Patient Screening Committee.\n* Prior or planned heart transplantation (UNOS status 1).\n* Physical evidence of right-sided CHF:\n\n  1. Patients with ascites.\n  2. Patients with anasarca (generalized edema \u002F hydropsy).\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy.\n\nProcedural Exclusion Criteria\n\n* Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).\n* Documented hypersensitivity to nickel or titanium.\n\nCardiac Imaging Exclusion Criteria (evaluated by Core Labs)\n\n* Contraindications to TEE imaging\n* Left ventricular EF ≤ 30% by echocardiogram.\n* Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.\n* Extensive mitral flail leaflets\n* Evidence of new or untreated intracardiac thrombus, mass, or vegetation.\n* Severe right ventricular dysfunction.\n* Severe tricuspid regurgitation.\n* Hemodynamically significant inter-atrial shunt (ASD).\n* Severe aortic regurgitation or aortic stenosis.\n* Anatomic ineligibility for SATURN Valve or SATURN TS procedure as determined by the Screening Committee.","18 Years",{"count":69,"type":22},15,[25],"CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US).\n\nThe purpose of the study is to evaluate the technical (implant) feasibility, and safety, and performance of the SATURN TS TMVR System for the treatment of moderate-severe or severe, symptomatic mitral regurgitation through a transcatheter approach.\n\nPrimary objectives evaluate the implant feasibility, and acute safety and performance of the SATURN TS TMVR System. The secondary objective and additional outcome measures characterize the long-term safety and performance of the SATURN TS TMVR System.",[30,73],"Heart Disease",[75,76,77],"Transcatheter","Mitral Valve","Replacement","RECRUITING","2026-08-06",{"date":81,"type":50},"2026-08-10",{"date":83,"type":50},"2026-08-05",{"date":85,"type":22},"2032-09",{"name":87,"class":88},"InnovHeart","INDUSTRY",5,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100551873","atlas-altavalve-pivotal-trial-100551873","NCT06465745","ATLAS (AltaValve) Pivotal Trial","ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial","ATLAS","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Symptomatic New York Heart Association (NYHA) class II-IV.\n* Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.\n* Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.\n\nExclusion Criteria (Abbreviated List):\n\n* Inability to understand the trial or a history of non-compliance with medical advice.\n* Inability to provide signed Informed Consent Form (ICF).\n* History of any cognitive or mental health status that would interfere with participation in the trial.\n* Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).\n* Female subjects who are pregnant or planning to become pregnant within the trial period.\n* Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.\n* Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.\n* Known hypersensitivity to contrast media that cannot be adequately medicated.\n* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.\n* Concurrent medical condition with a life expectancy of less than 12 months.\n* Transcatheter aortic repair or replacement within 90 days prior to the baseline required tests.\n* Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.",{"count":99,"type":22},450,[25],"This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.",[30,103,104,105,106],"Mitral Insufficiency","Mitral Valve Incompetence","Mitral Valve Regurgitation","Mitral Incompetence",[30,108,109,110,111,112,113],"TMVR","Functional Regurgitation","Degenerative Regurgitation","Transcatheter Mitral Valve Replacement","Primary Regurgitation","Secondary Regurgitation","2026-07-31",{"date":116,"type":50},"2026-08-03",{"date":118,"type":50},"2024-09-03",{"date":120,"type":22},"2031-09",{"name":122,"class":88},"4C Medical Technologies, Inc.",58,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":144,"locationsCount":146},"100627613","phase-1-the-revalve-clinical-trial-an-evaluation-of-the-revalve-palmetto-valve-for-the-replacement-of-the-native-mitral-valve-100627613","NCT07450911","The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE","A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System","The REsOLVE Tr","Key Inclusion Criteria:\n\n* Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)).\n* Age greater than 18 years\n* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.\n\nKey Exclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Status 1 heart transplant or prior orthotopic heart transplantation\n* Cerebrovascular accident within 30 days prior to subject's consent\n* Pregnant or planning pregnancy within next 12 months.\n* Currently participating in an investigational drug or another device study.\n* Evidence of LV or left atrium (LA) thrombus, vegetation or mass\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.",{"count":133,"type":22},20,[135],"PHASE1","An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.",[30],"2026-07-28",{"date":140,"type":50},"2026-07-29",{"date":142,"type":22},"2026-09-01",{"date":54,"type":22},{"name":145,"class":88},"ReValve Solutions Inc.",3,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":146},"100562209","capstan-medical-tmvr-study-fih-100562209","NCT06600191","Capstan Medical TMVR Study: FIH","Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of consent.\n* Moderate-severe (3+) or severe (4+) mitral regurgitation\n* NYHA II or greater symptoms despite optimal medical treatment.\n* The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).\n* Ability and willingness to provide written informed consent prior to any study related procedure(s).\n\nExclusion Criteria:\n\n* LVEF less than 20%\n* Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System\n* Severe aortic valve stenosis or regurgitation\n* Severe mitral stenosis\n* Severe right ventricular dysfunction or severe tricuspid valve disease\n* Evidence of intracardiac thrombus, vegetation, or mass\n* Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve\n* Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure\n* Myocardial infarction within 30 days prior to procedure\n* Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure\n* Active endocarditis, other ongoing infection requiring antibiotic therapy\n* Stroke or transient ischemic attack (TIA) within 30 days of procedure\n* Active peptic ulcer or active gastrointestinal bleeding\n* Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg\n* End-stage renal failure on dialysis\n* Life expectancy less than 1 year\n* Subject is on the waiting list for a heart transplant or has had a prior heart transplant\n* Pregnant (Participants of childbearing age are required to have a negative pregnancy test).\n* Known allergy to antiplatelet therapy, heparin, or to device materials\n* Inability to tolerate anticoagulation or antiplatelet therapies\n* Absence of appropriate venous access\n* Unable to have transesophageal echocardiography\n* Unwillingness to complete the required follow-up visits",{"count":155,"type":22},10,[25],"This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.",[30],[108,160],"mitral regurgitation","2026-07-14",{"date":163,"type":50},"2026-07-15",{"date":165,"type":50},"2025-02-24",{"date":167,"type":22},"2031-12",{"name":169,"class":88},"Capstan Medical",{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100443945","cephea-early-feasibility-study-100443945","NCT05061004","Cephea Early Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n* Need for emergent or urgent surgery.",{"count":177,"type":22},50,[25],"The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.",[30],"2026-07-07",{"date":183,"type":50},"2026-07-08",{"date":185,"type":50},"2022-04-28",{"date":187,"type":22},"2031-03-01",{"name":189,"class":88},"Abbott Medical Devices",22,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100477440","transcatheter-mitral-valve-replacement-in-patients-with-severe-symptomatic-mitral-regurgitation---apollo-eu-trial-100477440","NCT05496998","Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial","APOLLO-EU","Inclusion Criteria:\n\n* Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC\n* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements\n* Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 24 months\n* Currently surgically implanted mitral valve\n* Prior transcatheter mitral valve procedure with device currently implanted\n* Anatomic contraindications\n* Anatomically prohibitive mitral annular calcification (MAC)\n* Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment\n* LVEF \\\u003C 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \\\u003C30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)\n* Left ventricular end diastolic diameter (LVEDD) \\> 75mm\n* Need for emergent or urgent surgery\n* Hemodynamic instability\n* History of bleeding diathesis or coagulopathy\n* End stage renal disease\n* Liver failure\n* Frailty",{"count":200,"type":22},400,[25],"Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.",[30],[205,206,207,108,208,209,210],"mitral","valve","regurgitation","Intrepid™","symptomatic","severe","2026-07-01",{"date":213,"type":50},"2026-07-06",{"date":215,"type":50},"2023-02-07",{"date":217,"type":22},"2038-12",{"name":219,"class":88},"Medtronic Cardiovascular",37,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100534638","the-cardioclip-study-100534638","NCT06241430","The CardioClip Study","Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device","CardioClip","Inclusion Criteria:\n\n* Significant (moderate-severe \\[3+\\] or severe \\[4+\\] secondary MR)\n* Left ventricular dysfunction (ejection fraction \\>20% and \\\u003C50%)\n* New York Heart Association (NYHA) class II-IVa symptoms\n* Sign informed consent to participate in the study\n\nExclusion Criteria:\n\n* Left ventricular (LV) end-systolic dimension 70 mm\n* PA systolic pressure 70 mmHg (fixed)\n* Mitral valve (MV) orifice area \\\u003C4.0 cm2\n* Commissural MR jet or leaflet anatomy not suitable for mTEER\n* Likely to undergo heart transplantation or LV assist device implantation in the next 12 months\n* Recurrent (i.e., \\>1) pulmonary embolism or deep vein thrombosis\n* Complex congenital heart disease\n* Mechanical right heart valve (tricuspid or pulmonic)\n* Cardiac resynchronization therapy implanted within 3 months of enrollment\n* Hypersensitivity to aspirin and\u002For clopidogrel\n* History of medication non-adherence","90 Years",{"count":231,"type":22},60,[25],"The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.",[235,30],"Heart Failure With Reduced Ejection Fraction",[237,238,239,240,241,242,243,244,245,246],"Heart failure","Reduced ejection fraction","Mitral regurgitation","mTEER (mitral transcatheter edge-to-edge repair)","CardioMems (implantable pulmonary artery pressure sensor)","Guideline-directed medical therapy (GDMT)","HF hospitalization (HFH)","Clinical trial","Hemodynamic monitoring","Cardiovascular outcomes","2026-06-25",{"date":249,"type":50},"2026-06-29",{"date":251,"type":50},"2024-12-18",{"date":253,"type":22},"2030-06",{"name":255,"class":57},"Columbia University",1,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100644491","anchord-mitral-chordal-repair-system---fih-100644491","NCT07671820","Anchord Mitral Chordal Repair System - FIH","Anchord Mitral Chordal Repair System for Patients With Degenerative Mitral Regurgitation","Inclusion Criteria:\n\n* Severe symptomatic degenerative mitral regurgitation (grade 3+)\n* High surgical risk for open-heart mitral valve repair or replacement\n* Suitable anatomy for transcatheter chordal repair as determined by the treating physician\n* Ability to undergo required echocardiographic and fluoroscopic imaging\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Active endocarditis or systemic infection\n* Severe left ventricular dysfunction (LVEF \\\u003C30%)\n* Significant non-mitral valvular disease requiring intervention\n* Severe mitral annular calcification (MAC)\n* Presence of intracardiac or femoral venous thrombus or thrombus in the inferior vena cava\n* Cerebrovascular events (TIA, CVA) or thromboembolic events within the previous 6 months.\n* Renal insufficiency\n* Inability to undergo required imaging or access\n* Inability to tolerate standard anticoagulation or antithrombotic regimen\n* Rheumatic mitral valve disease\n* Co-morbid condition limiting life expectancy or study completion\n* Pregnancy\n* Participation in another clinical trial\n* Previous device treatment for MR.",{"count":89,"type":22},[25],"The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question\\[s\\] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.\n\nParticipants will be implanted with the Anchord device.",[30],"2026-06-23",{"date":270,"type":50},"2026-06-26",{"date":272,"type":22},"2026-07",{"date":274,"type":22},"2028-12",{"name":276,"class":88},"Lifecord Otd",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":283,"targetDuration":285,"studyType":286,"phases":4,"briefSummary":287,"conditions":288,"keywords":295,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":305},"100598298","abbott-cephea-mitral-valve-disease-registry-100598298","NCT07069673","Abbott Cephea Mitral Valve Disease Registry","Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.",{"count":284,"type":22},1000,"2 Years","OBSERVATIONAL","The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",[30,289,290,291,292,293,294],"Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[290,296,297],"registry","Cephea Mitral Valve System","2026-06-18",{"date":300,"type":50},"2026-06-22",{"date":302,"type":50},"2025-08-13",{"date":274,"type":22},{"name":189,"class":88},23,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"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":315,"type":22},300,"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.",[29,30,318,319],"Tricuspid Regurgitation","Transcatheter Aortic Valve Implantation (TAVI)",[321,322,323,239,324,325,326],"Aortic stenosis","Transcatheter aortic valve implantation (TAVI)","Multivalvular heart disease","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","2026-05-28",{"date":329,"type":50},"2026-06-03",{"date":331,"type":22},"2026-06-05",{"date":333,"type":22},"2034-06-05",{"name":335,"class":57},"Josep Rodes-Cabau",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":343,"targetDuration":345,"studyType":286,"phases":4,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":256},"100638048","active-post-market-surveillance-of-innovative-devices-for-valvular-heart-disease-100638048","NCT07605624","Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease","An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease","Inclusion Criteria:\n\n* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems\n* Age ≥ 18 years\n* Patients who voluntarily participate in the study and sign the informed consent form\n* Willing and able to comply with follow-up requirements",{"count":344,"type":22},5500,"1 Year","This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.",[29,348,30,318],"Aortic Regurgitation","2026-05-18",{"date":351,"type":50},"2026-05-26",{"date":353,"type":22},"2026-05-10",{"date":355,"type":22},"2029-01-31",{"name":357,"class":57},"Beijing Anzhen Hospital",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},"100420927","annuloplasty-rings-and-band-post-market-clinical-follow-up-study-100420927","NCT04761120","Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study","Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study","ARB-PMCF","Inclusion Criteria:\n\n1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:\n\n   1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair\n   2. implant of a full Tailor Ring without cut zone removal for TR repair, or\n   3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.\n2. Subject's cardiac surgery will be performed by a study investigator.\n3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).\n4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.\n\nExclusion Criteria:\n\n1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.\n2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.\n3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).\n4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).\n5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.\n6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements",{"count":367,"type":22},550,"ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.",[30,318,370],"Valvular Heart Disease",[30,318,372,373,374,375,376,377,378,379],"Valve Surgery","Valve Repair","Annuloplasty Rings","Annuloplasty Bands","Rigid Saddle Ring","Séguin Annuloplasty Ring","Tailor Annuloplasty Ring","Tailor Annuloplasty Band","2026-05-14",{"date":349,"type":50},{"date":383,"type":50},"2021-02-01",{"date":385,"type":22},"2031-03",{"name":189,"class":88},17,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100415327","choice-of-optimal-transcatheter-treatment-for-mitral-insufficiency-registry-100415327","NCT04688190","CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry","Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry","CHOICE-MI","Inclusion Criteria:\n\n* clinically significant mitral insufficiency\n* patient underwent screening for TMVI\n* echocardiography data at baseline (and after TMVI, E2E and surgery)\n* follow-up of at least 30 days\n\nExclusion Criteria:\n\n\\- age under 18 years",{"count":284,"type":22},"This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.\n\nPatients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical\u002Fconservative therapy.",[30,290,399],"Mitral Annular Calcification","2026-05-03",{"date":402,"type":50},"2026-05-07",{"date":404,"type":50},"2020-11-01",{"date":406,"type":22},"2030-12-31",{"name":408,"class":57},"Universitätsklinikum Hamburg-Eppendorf",43,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":256},"100558182","left-atrial-monitoring-in-patients-before-and-after-mitral-surgery---lambda-study-100558182","NCT06547788","LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY","LAMBDA","Inclusion Criteria:\n\n* Patients ≥18 years of age\n* Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease\n* Planned surgical mitral valve repair\n* Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline\n* Pulmonary vascular resistance ≤ 4 Wood units\n\nExclusion Criteria:\n\n* Secondary causes of MR and mixed mitral valve disease\n* Infective endocarditis within 30-days\n* Any prior mitral valve intervention\n* Need for emergency intervention or surgery\n* Left ventricular ejection fraction 2+",{"count":177,"type":22},[25],"Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR.\n\nThe standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS).\n\nPrevious studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.",[30,290,40],"2026-04-29",{"date":423,"type":50},"2026-05-06",{"date":425,"type":22},"2026-09-30",{"date":427,"type":22},"2030-01-31",{"name":429,"class":57},"Ottawa Heart Institute Research Corporation",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100462166","transcatheter-mitral-valve-repair-for-inotrope-dependent-cardiogenic-shock-100462166","NCT05298124","Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock","MINOS","Inclusion Criteria:\n\n1. Participants or substitute decision maker is able and willing to provide written informed consent\n2. Age ≥ 18 years\n3. SCAI stage C or D cardiogenic shock with persistent inotrope\u002Fvasopressor\u002Fnon-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization\n4. Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)\n5. In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve \\\u003C3+ MR\n\nExclusion Criteria:\n\n1. Unwilling or unable to obtain informed consent from the participant or substitute decision maker\n2. Revascularization of coronary artery disease performed in the 48 hours prior to randomization\n3. If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention\n4. Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)\n5. Echocardiographic evidence of left sided intracardiac mass or thrombus\n6. Diagnosis of active infective endocarditis\n7. Transesophageal echocardiogram is contraindicated\n8. Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team\n9. Any aortic valve disease greater than moderate in severity\n10. A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically\n11. Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery\n12. Plan for durable mechanical circulatory support implantation prior to TMVr\n13. In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital\n14. Pregnant or planning to become pregnant in the next 6 months.",{"count":438,"type":22},144,[25],"Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.\n\nThis study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited.\n\nThe study aims to answer the question: \"Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?\"\n\nThe study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.",[442,30],"Cardiogenic Shock",{"date":423,"type":50},{"date":445,"type":50},"2022-05-26",{"date":447,"type":22},"2028-05",{"name":429,"class":57},4,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":458,"targetDuration":459,"studyType":286,"phases":4,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":471,"leadSponsor":472,"locationsCount":4},"100634760","mitraclip-generation-5-mitral-valve-transcatheter-edge-to-edge-repair-registry-100634760","NCT07543874","MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry","MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry (MITRAGEN5 Registry)","MITRAGEN5","Inclusion Criteria:\n\n* Age 18 years or older at the time of M-TEER\n* Treatment using the MitraClip G5 system\n\nExclusion Criteria:\n\n\\- None",{"count":284,"type":22},"30 Days","The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.",[30],[463,464,465,466],"MitraClip","Mitral Valve Transcatheter Edge-to-Edge Repair","M-TEER","MitraClip G5","2026-04-27",{"date":469,"type":50},"2026-05-01",{"date":469,"type":22},{"date":406,"type":22},{"name":473,"class":57},"University Hospital of Cologne",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":256},"100599595","a-clinical-study-of-geminione-teer-system-for-the-treatment-of-severe-symptomatic-mr-100599595","NCT07086534","A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.","A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).","Inclusion Criteria:\n\n1. Age 18 years or older(≥ 18 years)\n2. Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)\u002F (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.\n\n   For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or \\> 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.\n3. Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.\n4. Feasible transseptal catheterization and femoral vein access.\n5. Written informed consent from subject or legal representative.\n\nExclusion Criteria:\n\n1. History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.\n2. Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.\n3. Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.\n4. Left ventricular ejection fraction (LVEF)\\\u003C 20%\n5. Left ventricular end-systolic diameter(LVESD)\\> 60mm\n6. Mobile leaflet length less than 10mm\n7. Mitral valve effective orifice area (EOA) \\\u003C 3.5cm or a high risk of mitral stenosis developing after device implantation, as judged by site investigators, core lab, and eligibility committee.\n8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n9. Presence of severe non-mitral valve disease requiring intervention.\n10. Severe pulmonary artery hypertension(sPAP \\>70mmHg).\n11. Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.\n\n13\\. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.\n\n14.Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.\n\n16\\. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \\\u003C 25 mL\u002Fmin.\n\n17\\. Blood cachexia including granulocytopenia(WBC\\\u003C3x10\\^9\u002FL),acute anemia(HB \\\u003C90g\u002FL)thrombocytopenia (PLT \\\u003C50x10\\^9\u002FL), severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy.\n\n18\\. Evidence of an acute myocardial infarction within the past 4 weeks. 19.Evidence of stroke within the prior 90 days. 20. Any percutaneous cardiac intervention, carotid surgery, or any cardiac surgery within 30 days prior to procedure.\n\n21\\. Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging.\n\n22\\. Subjects with underlying medical or psychiatric conditions that may interfere with trial evaluation (e.g. cancer, infection, severe metabolic disease). Additionally, any case deemed unsuitable for the study by the local heart team.\n\n23.Life expectancy of less than 12 months. 24. Participation in another investigational drug or device study within the past 1 month.\n\n25\\. Subjects deemed unlikely to complete the trial due to potential non-compliance, as judged by the investigator.\n\n26\\. Any anatomic characteristic or presence of atrial septal occluders, which would preclude the performance of the transseptal approach.",{"count":69,"type":22},[25],"To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.",[30],"2026-04-21",{"date":487,"type":50},"2026-04-24",{"date":489,"type":50},"2026-03-26",{"date":491,"type":22},"2031-05-31",{"name":493,"class":88},"Sierra Valve LLC",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":502,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100632738","efs-of-posterior-leaflet-replacement-to-reduce-mitral-regurgitation-united-states-100632738","NCT07517588","EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)","Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)","EXPLORE-MRace","Inclusion Criteria:\n\n1. Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.\n\n   Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of \\> 50% or increase of \\> 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.\n2. Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.\n3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure\n4. Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.\n5. The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies\n6. 21 years of age or older\n7. Native mitral valve geometry and size is compatible with the Polares MRace system\n8. Anatomy is suitable for transfemoral transseptal access with the Polares MRace system\n9. Patient is willing to participate in study and provides signed IRB\u002FEC-approved informed consent\n10. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits\n11. Patient is approved by an independent Patient Eligibility Committee\n\nExclusion Criteria:\n\n1. Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)\n\n   1. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n   2. Pulmonary artery systolic pressure (PASP) \\> 70mmHg or \\> 2\u002F3 SBP (Systolic Blood Pressure)\n   3. Left Ventricle End Diastolic Volume (LV EDV) \\> 200 mL\n   4. Left Ventricle End Systolic Volume (LV ESV) \\> 140 mL\n   5. Left Ventricle End Diastolic Diameter (LV EDD) \\> 70 mm\n   6. Left Ventricle End Systolic Diameter (LV ESD) \\> 55 mm\n2. Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .\n3. Severe tricuspid regurgitation.\n4. Severe aortic stenosis or insufficiency.\n5. Severe mitral annulus calcification.\n6. Diseased mitral anterior and\u002For posterior leaflet, such as flail, \u002F prolapse, or\u002F heavy moderate to severe calcification.\n7. Barlow's disease.\n8. Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.\n9. Contraindication for transesophageal echocardiography (TEE) or MDCT scan\n10. Active infection or endocarditis or infection requiring antibiotic therapy within 2 weeks of scheduled procedure.\n11. Previous mitral valve surgery or transcatheter mitral valve procedure.\n12. Prior orthotopic heart transplantation.\n13. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus. History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months of the index procedure.\n14. Untreated Class I indication for pacing (CRT). Implant or revision of any pacing device \\\u003C 30 days prior to intervention\n15. Any untreated clinically significant coronary artery disease requiring revascularization. Coronary, carotid, or endovascular artery disease treated percutaneously \\\u003C 30 days prior to study procedure. Cardiac surgery \\\u003C 90 days prior to study procedure.\n16. Myocardial infarction requiring intervention \\\u003C 30 days prior to study procedure\n17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis)\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to study procedure.\n19. Stroke \\\u003C 180 days prior to study procedure.\n20. Severe COPD requiring oral steroid therapy or oxygen therapy.\n21. Severe renal insufficiency (creatinine \\> 3.0 mg\u002FdL) or patient requiring dialysis\n22. Cardiogenic shock at time of enrolment. Hemodynamic instability requiring inotropic support or mechanical heart assistance.\n23. Concurrent medical condition with a life expectancy of less than 2 years\n24. Pregnancy or breastfeeding at time of enrolment with a positive pregnancy test within 14 days of study procedure.\n25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \\\u003C 3,000 mcL) or acute anemia (Hb \\\u003C 9 g\u002FdL) or thrombocytopenia (platelets \\\u003C 50,000 cells mcL)\n26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated.\n\n    Note. Patient must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.\n27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial\u002Fprocedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments.\n28. Patient is in need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n29. Company employees or their immediate family members.\n30. Patient is considered to be part of a vulnerable population, is under guardianship, or subject to any other medical, social or psychological conditions that preclude appropriate consent and follow-up.\n31. Patient is participating in another clinical study for which follow-up is currently ongoing.","21 Years",{"count":69,"type":22},[25],"The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are:\n\nDoes implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve?\n\nParticipants will:\n\nBe implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey",[30],"2026-04-03",{"date":509,"type":50},"2026-04-08",{"date":511,"type":22},"2026-06-01",{"date":513,"type":22},"2031-12-31",{"name":515,"class":88},"Polares Medical SA",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":256},"100593492","phase-4-strategies-for-antithrombotic-treatment-following-transcatheter-edge-to-edge-repair-in-patients-without-an-indication-for-oral-anticoagulant-100593492","NCT07007143","STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant","STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients Without an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial","STAR-TEER Ⅱ","Inclusion Criteria:\n\n* Successful TEER procedure, defined as technical success per MVARC criteria.\n* Ability and willingness to comply with the trial protocol.\n* Provision of written informed consent.\n* Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy.\n* Antithrombotic strategy approved by the investigator.\n\nExclusion Criteria:\n\n* Severe renal impairment (creatinine clearance \\\u003C 15 mL\u002Fmin or requiring dialysis).\n* Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g\u002FdL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure.\n* Platelet count \\\u003C 50 × 10\\^9 \u002FL.\n* Need for reoperation due to complications of the index TEER procedure.\n* Recent ( \\\u003C 12 month) intracranial or intracerebral hemorrhage.\n* Recent ( \\\u003C 12 month) gastrointestinal ulcers or hemorrhage.\n* Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis).\n* Allergy, intolerance, or contraindication to research drugs.\n* Participation in another investigational drug or device study within 30 days.\n* Indication for long-term OAC.\n* Absolute indication for dual antiplatelet therapy; (eg, recent PCI).\n* Life expectancy \\\u003C 12 months.\n* Pregnancy or breastfeeding.",{"count":525,"type":22},1032,[527],"PHASE4","Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients undergone TEER procedure. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients without an indication for OAC.",[30],[531,30,532,533,534,535,536,537,538,539,540,541,542,543],"Transcatheter Edge-to-Edge Repair (TEER)","Cardiovascular Diseases","Embolism and Thrombosis","Bleeding","Aspirin","Clopidogrel","Antithrombotic treatment","Platelet Aggregation Inhibitors","Antiplatelet Drug","Single Antiplatelet Therapy（SAPT）","Double Antiplatelet Therapy（DAPT）","Stroke","Myocardial Infarction","2026-03-05",{"date":546,"type":50},"2026-03-09",{"date":548,"type":50},"2025-07-31",{"date":550,"type":22},"2029-09-30",{"name":552,"class":57},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":256},"100585369","phase-4-strategies-for-antithrombotic-treatment-following-transcatheter-edge-to-edge-repair-in-patients-with-an-indication-for-oral-anticoagulant-100585369","NCT06901466","STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant","STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial","STAR-TEER Ⅰ","Inclusion Criteria:\n\n* Successful TEER procedure, defined as technical success per MVARC criteria.\n* Indication for long-term OAC.\n* Ability and willingness to comply with the trial protocol.\n* Provision of written informed consent.\n* Women of childbearing potential must use effective contraception from the time of consent until the final dose of antithrombotic therapy.\n* Antithrombotic strategy approved by the investigator.\n\nExclusion Criteria:\n\n* Severe renal impairment (creatinine clearance \\\u003C 15 mL\u002Fmin or requiring dialysis).\n* Ongoing postoperative bleeding (defined as overt bleeding with a ≥3.0 g\u002FdL drop in hemoglobin or requiring ≥3 units of blood transfusion), or vascular complications following the index TEER procedure.\n* Platelet count \\\u003C 50 × 10\\^9 \u002FL.\n* Need for reoperation due to complications of the index TEER procedure.\n* Recent ( \\\u003C 12 month) intracranial or intracerebral hemorrhage.\n* Recent ( \\\u003C 12 month) gastrointestinal ulcers or hemorrhage.\n* Hepatic disease with coagulopathy.(eg, Child-Pugh class B or C cirrhosis).\n* Allergy, intolerance, or contraindication to research drugs.\n* Participation in another investigational drug or device study within 30 days.\n* History of stroke or TIA within the past 6 weeks.\n* Absolute indication for anticoagulation in combination with antiplatelet therapy (eg, recent PCI).\n* Life expectancy \\\u003C 12 months.\n* Pregnancy or breastfeeding.",{"count":562,"type":22},880,[527],"Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.",[30],[531,30,532,533,534,535,567,537,568,538,542,543],"Rivaroxaban","Oral anticoagulation",{"date":546,"type":50},{"date":571,"type":50},"2025-06-13",{"date":573,"type":22},"2028-10-31",{"name":552,"class":57},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":598},"100374271","the-encircle-trial-100374271","NCT04153292","The ENCIRCLE Trial","SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access","ENCIRCLE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. MR ≥ 3+\n3. NYHA functional class ≥ II\n4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.\n5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.\n6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Mitral\u002Fcardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve\n2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve\n3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation\n4. Left ventricular ejection fraction \\\u003C25%\n5. Severe right ventricular dysfunction\n6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months\n7. History of heart transplant\n8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n9. Active bacterial endocarditis within 180 days of the procedure\n10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure\n11. Myocardial infarction within 30 days of the procedure\n12. Clinically significant untreated coronary artery disease requiring revascularization\n13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure\n14. Stroke or transient ischemic attack within 90 days of the procedure\n15. Irreversible, severe pulmonary hypertension\n16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use\n17. Renal insufficiency or receiving renal replacement therapy\n18. Liver disease\n19. Planned surgery within the next 12 months\n20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure\n21. Active infection requiring current antibiotic therapy\n22. Active SARS-CoV-2 infection (Coronavirus-19 \\[COVID-19\\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states\n24. Refusal of blood products\n25. Female who is pregnant or lactating\n26. Estimated life expectancy \\\u003C12 months due to non-cardiac conditions\n27. Participating in another investigational drug or device study that has not reached its primary endpoint\n28. Subject considered to be part of a vulnerable population",{"count":584,"type":22},900,[25],"This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.\n\nFollowing completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.",[30,588],"Mitral Valve Insufficiency","2026-02-23",{"date":591,"type":50},"2026-02-25",{"date":593,"type":50},"2020-11-12",{"date":595,"type":22},"2031-02-28",{"name":597,"class":88},"Edwards Lifesciences",68,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":606,"targetDuration":608,"studyType":286,"phases":4,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":256},"100624411","the-embrace-registry-european-post-market-registry-for-catheter-based-mitral-valve-replacement-100624411","NCT07409285","The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement","EMBRACE","Inclusion Criteria: Participants must fulfill all following inclusion criteria in order to be included in the post market registry:\n\n1. Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)\n\n   * Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and\u002For secondary (i.e. functional MR.\n   * Left Ventricular Ejection Fraction (LVEF) ≥ 30%\n   * Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm\n2. Based on the assessment of the local multidisciplinary heart team, the participant is:\n\n   1. unsuitable for heart surgery (mitral valve repair or replacement)\n   2. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy)\n   3. eligible to receive the HighLife TSMVR system per the current approved Instructions For Use (IFU) and as assessed by the local heart team\n\nExclusion Criteria: Participants will be excluded from the post market registry as per the current approved Instructions For Use (IFU) if any of the following criteria is met:\n\n1. Significantly calcified mitral valves;\n2. Severe mitral annular calcification\n3. Narrow femoral arteries that don't allow the passage of 18F sheaths;\n4. More than 80 cm between the aortic valve and the femoral access;\n5. Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE);\n6. Intolerance to anticoagulation\u002Fantiplatelet regimens or procedural anticoagulation;\n7. Active bacterial endocarditis or other active infections;\n8. Allergies to contrast media;\n9. Previous implanted aortic valve prosthesis;\n10. Evidence of intracardiac mass, thrombus, or vegetation.\n11. Participant enrolled in another clinical study that may impact the follow-up or results of this study.\n12. Participant has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the patient's ability to participate in the clinical study or to comply with follow-up requirements.\n13. Tricuspid valve disease requiring intervention",{"count":607,"type":22},150,"3 Years","Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.",[30],"2026-02-06",{"date":613,"type":50},"2026-02-13",{"date":615,"type":22},"2026-03-14",{"date":617,"type":22},"2031-04-15",{"name":619,"class":88},"HighLife SAS",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":636,"locationsCount":638},"100425499","efs-of-the-cardiomech-mvrs-100425499","NCT04820764","EFS of the CardioMech MVRS","Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)","Inclusion Criteria:\n\n* Eighteen (18) years of age or greater\n* Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail\n* Intermediate or high surgical risk for mitral valve repair\n\nExclusion Criteria:\n\n* History of rheumatic heart disease\n* History of prior endocarditis\n* History of prior repair or replacement of the mitral valve, or annuloplasty\n* Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment\n* Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging",{"count":7,"type":22},[25],"Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.",[30],{"date":632,"type":50},"2026-02-10",{"date":634,"type":50},"2021-07-27",{"date":120,"type":22},{"name":637,"class":88},"CardioMech AS",12,{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":179,"conditions":647,"keywords":648,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":146},"100611773","cephea-south-america-feasibility-study-100611773","NCT07244939","Cephea South America Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function\n* Need for emergent or urgent surgery",{"count":133,"type":22},[25],[30,289],[649,297],"Symptomatic mitral valve disease","2026-02-05",{"date":611,"type":50},{"date":653,"type":50},"2025-06-17",{"date":655,"type":22},"2028-09",{"name":189,"class":88}]