[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-insufficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,52,76,98,127,151,173,205,230,253,276,302],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100296681","the-empower-trial---the-carillon-mitral-contour-system-in-treating-heart-failure-with-fmr-100296681",false,"NCT03142152","The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR","Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation","Inclusion Criteria:\n\n1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity\n2. NYHA II, III, or IV\n3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters\n4. Left Ventricular Ejection Fraction ≤ 50%\n5. LVEDD:\n\n   * ≥ 55 mm (women)\n   * ≥ 57 mm (men)\n6. LVESD ≤ 75 mm\n7. Corrected NT-proBNP \\> 1200 pg\u002Fml measured within 60 days of randomization, and\u002For one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.\n8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee\n9. Age ≥ 18 years old\n10. Carillon implant can be sized and placed in accordance with the IFU\n11. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent\n\nExclusion Criteria:\n\n1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device\n2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)\n3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement\n4. Severe mitral annular calcification\n5. Severe aortic stenosis\n6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year\n7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study\n\n   * An entire list of eligibility is available in the clinical investigational plan","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).",[26,27,28,29,30,31],"Functional Mitral Regurgitation","Heart Failure","Mitral Valve Insufficiency","Heart Diseases","Cardiovascular Diseases","Heart Valve Diseases",[26,33,34,35,36,37,38],"Percutaneous Mitral Valve Repair","Percutaneous Mitral Valve Annuloplasty","Coronary Sinus Annuloplasty","Secondary Mitral Regurgitation","Functional MR","FMR","RECRUITING","2026-04-08",{"date":42,"type":43},"2026-04-13","ACTUAL",{"date":45,"type":43},"2018-01-01",{"date":47,"type":20},"2030-12-31",{"name":49,"class":50},"Cardiac Dimensions, Inc.","INDUSTRY",92,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"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":61,"type":20},900,[23],"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.",[65,28],"Mitral Regurgitation","2026-02-23",{"date":68,"type":43},"2026-02-25",{"date":70,"type":43},"2020-11-12",{"date":72,"type":20},"2031-02-28",{"name":74,"class":50},"Edwards Lifesciences",68,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100510515","dragonfly-eu-pivotal-study-100510515","NCT05927441","DragonFly EU Pivotal Study","Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation","Inclusion Criteria:\n\n* ≥18 years old\n* New York Heart Association (NYHA) Class II-IV\n* Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography (For DMR cohort)\n* Symptomatic FMR ≥ 3+ due to ischemic or non-ischemic cardiomyopathy (For FMR cohort)\n* Transseptal catheterization and femoral vein access are determined to be feasible\n* Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF\n\nExclusion Criteria:\n\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* Other severe heart valve diseases requiring intervention\n* Prior mitral valve leaflet surgery (prior annuloplasty ring not excluded) or previous transcatheter mitral valve intervention\n* Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization\n* Any cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to the procedure; or in the judgment of the investigator, the femoral vein cannot accommodate a 25 F catheter or the presence of an inferior vena cava filter would interfere with advancement of the catheter or ipsilateral deep vein thrombosis is present; or the patient's anatomy is not suitable for atrial septal puncture\n* Patients in whom TEE or general anesthesia is contraindicated\n* End stage heart failure (ACC\u002FAHA stage D); or after heart transplantation; or waiting for a heart transplantation\n* Active endocarditis or active rheumatic heart disease; or mitral valve changes due to endocarditis and rheumatic heart valve disease\n* History of ischemia cerebrovascular accident in the past 30 days, or severe symptomatic carotid stenosis (ultrasonic examination showed stenosis degree \\>70%); or carotid stent implantation within 30 days; hemorrhagic cerebrovascular accident occurred within 6 months\n* History of acute peptic ulcer or gastrointestinal bleeding within 3 months\n* Hemorrhagic disease or coagulation disorder; or contraindicated of antithrombotic drug treatment\n* Modified Rankin scale ≥ 4\n* Diseases that make the evaluation of treatment difficult (e.g., cancer, severe metabolic disease, psychosis)\n* Pregnant or lactating women\n* Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg without afterload reduction medicine, or cardiogenic shock, or need for an intra-aortic balloon pump, or other hemodynamic support devices\n* Active infections requiring current antibiotic therapy (if temporary illness, patients may be enrolled 2 weeks after discontinuation of antibiotics)\n* Currently participating in an investigational drug or another device study of which the primary endpoint has not been completed, or it that clinically interferes with the current study endpoints. (Note: extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational study)\n* In the judgment of the investigator, the patients' compliance will be poor and could not complete the study as required, or other conditions indicate that the subject is not suitable to participate in the study",{"count":84,"type":20},168,[23],"To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.",[28],"2025-11-19",{"date":90,"type":43},"2025-11-24",{"date":92,"type":43},"2024-01-01",{"date":94,"type":20},"2029-05-01",{"name":96,"class":50},"Hangzhou Valgen Medtech Co., Ltd",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":97},"100598218","korea-vhd-echo-study-surveillance-of-aortic-mitral--tricuspid-patients---insights-from-real-world-practice-100598218","NCT07068633","Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice","Inclusion Criteria:\n\n* Period: 2010.1.1\\~2020.12.31\n* Age \\> 18 years\n* Moderate or severe native VHD (AS, AR, MR and TR)\n* Perform echocardiography more than twice\n\nExclusion Criteria:\n\n* Poor image of echocardiography\n* Follow up loss","19 Years",{"count":106,"type":20},30000,"OBSERVATIONAL","Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.\n\nSouth Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.",[31,110,111,28,112,113,114,115],"Aortic Valve Stenosis","Aortic Valve Insufficiency","Mitral Valve Prolapse","Tricuspid Valve Insufficiency","Rheumatic Heart Disease","Aortic Diseases","NOT_YET_RECRUITING","2025-07-07",{"date":119,"type":43},"2025-07-16",{"date":121,"type":20},"2025-08",{"date":123,"type":20},"2027-12-31",{"name":125,"class":126},"Yonsei University","OTHER",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":135,"targetDuration":137,"studyType":107,"phases":4,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":97},"100574266","clinical-outcomes-of-edwards-lifesciences-mitris-reslila-mitral-valve-in-the-asian-population-100574266","NCT06757049","Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population","Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population(THE KOREA MITRIS REGISTRY)","KOREA MITRIS","Inclusion Criteria:\n\n1. Age 19 or older\n2. Requires mitral valve replacement due to mitral valve dysfunction\n3. The participant or their guardian can provide a written consent form approved by the IRB and agree to the research protocol and clinical follow-up schedule.\n\nExclusion Criteria:\n\n1. Life expectancy of less than one year due to causes other than cardiovascular disease\n2. High-risk candidates for mitral valve replacement: Society of Thoracic Surgeons Predicted Risk of Mortality 10% or greater; EuroSCORE 10% or greater; estimated surgical mortality rate by the surgeon 10% or greater\n3. Chronic kidney disease: eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²\n4. Undergoing surgery for infective endocarditis",{"count":136,"type":20},200,"60 Months","The purpose of this study is to evaluate the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients in a real-world setting",[28],[141],"Mitral Valve Replacement","2024-12-26",{"date":144,"type":43},"2025-01-03",{"date":146,"type":43},"2024-12-20",{"date":148,"type":20},"2031-03-31",{"name":150,"class":126},"Asan Medical Center",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":157,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":97},"100573087","a-study-of-mitral-annular-disjunction-in-mitral-valve-prolapse-patients-and-arrhythmia-risk-100573087","NCT06741709","A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk","Inclusion Criteria:\n\n* All consecutive patients \\> 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.\n\nExclusion Criteria:\n\n* Previous mitral valve surgery.\n\n  * MVP due to infective endocarditis.\n  * Moderate or more significant aortic stenosis, aortic regurgitation or mitral stenosis.\n  * Congenital heart disease and poor image quality precluding accurate assessment of the mitral valve.","18 Months",{"count":159,"type":20},30,"This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.",[112,28],[163],"Mitral annular disjunction","2024-12-15",{"date":166,"type":43},"2024-12-19",{"date":168,"type":20},"2025-02-14",{"date":170,"type":20},"2026-12-30",{"name":172,"class":126},"Assiut University",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":182,"conditions":183,"keywords":193,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":97},"100534173","european-association-of-cardiovascular-imaging-multiple-and-mixed-valvular-disease-study-100534173","NCT06235385","European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study","EACVI-MMVD","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient referred to the cardiovascular imaging department.\n3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:\n\n   1. Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.\n\n      and\u002For\n   2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.\n4. Patient not refusing to have their data involved in the protocol after information.\n\nExclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):\n\n1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).\n2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months.\n3. Complex congenital heart diseases.",{"count":181,"type":20},1500,"This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.",[31,184,185,110,111,186,187,188,28,189,190,113,191,192],"Multiple Valve Disease, Unspecified","Aortic Valve Disease","Mitral Valve Disease","Mitral Valve Stenosis","Mitral Valve Insufficiency and Aortic Valve Insufficiency","Aortic Valve Stenosis With Insufficiency","Mitral Valve Disease Mixed","Tricuspid Valve Disease","Tricuspid Stenosis",[194,195],"Multiple Valvular Heart Disease","Mixed Valvular Heart Disease","2024-05-31",{"date":198,"type":43},"2024-06-03",{"date":200,"type":43},"2024-02-07",{"date":202,"type":20},"2029-08-01",{"name":204,"class":126},"Assistance Publique - Hôpitaux de Paris",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":215,"studyType":107,"phases":4,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":97},"100359588","prognostic-impact-of-imaging-parameters-in-patients-with-primary-mitral-insufficiency-by-prolapse-cohorte-im-100359588","NCT03962023","Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)","Prognostic Impact of Non-invasive Imaging Parameters (Cardiac Echocardiography and MRI) in Patients With Primary Mitral Insufficiency (MI) by Prolapse: Observational Cohort, Monocentric (COHORTE-IM)","COHORTE-IM","Inclusion Criteria:\n\n* Any patient with primary mitral insufficiency by prolapse (any grade) diagnosed by Trans-Thoracic Echocardiography (TTE)\n* From November 2010 to April 2019 (retrospective cohort)\n* From May 2019 to May 2024 (prospective cohort)\n* No previous surgery of the mitral valve before the first ultrasound\n* Adults\n* Patient who has been informed and not opposed to the use of his or her medical record data\n\nExclusion Criteria:\n\n* Secondary MI\n* Primary MI without valve prolapse\n* Active endocarditis\n* Patient's refusal to participate in the study\n* Patient under guardianship or curatorship",{"count":214,"type":20},400,"10 Years","Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and\u002For echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up).\n\nIt is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring.\n\nA number of echocardiographic and MRI parameters may have been associated with a poorer prognosis.\n\nA cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.",[28],[28,219,220],"Imagery","Prognosis","2024-03-25",{"date":223,"type":43},"2024-03-26",{"date":225,"type":43},"2019-09-04",{"date":227,"type":20},"2034-09",{"name":229,"class":126},"Lille Catholic University",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100388858","the-half-moon-transcatheter-mitral-valve-repair-tmvr-pilot-study-100388858","NCT04343313","The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study","Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation","Key Inclusion Criteria:\n\n1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)\n2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team\n3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies\n4. Age ≥ 21\n5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant\n6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System\n7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits\n\nKey Exclusion Criteria:\n\n1. Prior transseptal intervention with occlusion device currently implanted\n2. Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system\n3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation\n4. Prohibitive mitral annular or leaflet calcification\n5. Diseased mitral anterior leaflet such as flail or prolapse\n6. Left ventricular ejection fraction (LVEF) \\\u003C 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) \\>120mL\u002Fm2 as measured by resting echocardiogram within 30 days of the Index Procedure\n7. Left ventricular end diastolic diameter (LVEDD) \\> 75mm\n8. Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2\u002F3 systemic systolic pressure\n9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction\n10. Severe tricuspid regurgitation\n11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery\u002Fprocedure\n12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment\n13. Prior stroke, TIA, or myocardial infarction within 90 days\n14. Need for coronary revascularization\n15. Severe symptomatic carotid artery stenosis\n16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \\\u003C 750cc\n17. Need for emergent surgery\n18. Endocarditis within 6 months\n19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment\n20. GI bleeding within 6 months\n21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion\n22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support\n23. Platelet count of \\\u003C75,000 cells\u002Fmm3\n24. Renal insufficiency (Creatinine \\> 2.5 mg\u002FdL)\n25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)\n26. Contraindication to transesophageal echocardiography (TEE)\n27. Known hypersensitivity or contraindication to study or procedure medications\u002Fcontrast which cannot be adequately managed medically\n28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)\n29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint","21 Years","95 Years",{"count":159,"type":20},[23],"The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.",[28],"2024-01-10",{"date":245,"type":43},"2024-01-12",{"date":247,"type":43},"2020-12-08",{"date":249,"type":20},"2029-12-31",{"name":251,"class":50},"Half Moon Medical",5,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":97},"100478320","to-evaluate-the-efficacy-and-safety-of-the-transfemoral-mitral-valve-repair-system-in-the-treatment-of-patients-with-moderately-severe-and-severe-functional-mitral-regurgitationfmr-who-remained-clinically-symptomatic-after-guideline-directed-medical-treatment-100478320","NCT05508438","To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment","A Prospective, Multicenter, Objective Performance Criteria Clinical Study to Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR)","Inclusion Criteria:\n\n* 1.Age ≥ 18 yrs；\n* 2\\. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy\n\nNote 1: Functional MR requires the presence of overall or localized left ventricular wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.\n\nNote 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), or at least 30 days under the following conditions after meeting two of the following conditions：Coronary revascularization and\u002For implantation of a cardiac resynchronization therapy device (CRT-P or CRT-D) or reprogramming of the implanted CRT-P or CRT-D resulting in an increase in biventricular pacing (from \\\u003C92% to ≥92%).\n\n* 3\\. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and\u002For have received stable GDMT, confirmed by the local heart team;\n* 4\\. NYHA functional class II to IV;\n* 5\\. Left ventricular ejection fraction (LVEF) ≥20%;\n* 6\\. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm;\n* 7\\. The subject's mitral valve is anatomically suitable for mitral valve repair;\n* 8\\. Elevated BNP \\>150 pg\u002Fml or corrected NT-proBNP ≥600 pg\u002Fml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg\u002Fm2 in BMI above a reference BMI of 20 kg\u002Fm2);\n* 9\\. After evaluation, the femoral vein approach is suitable and the puncture through atrial septum is feasible;\n* 10\\. The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;\n* 2\\) The presence of other severe heart valve disease requiring surgical intervention.;\n* 3\\) After mitral valve surgery or mitral valve transcatheter surgery;\n* 4)Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.;\n* 5\\) Autoimmune myocarditis;\n* 6\\) Heart failure caused by tachyarrhythmia is effective after GDMT treatment;\n* 7\\) Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \\> 70 mmHg assessed by echocardiography;\n* 8\\) History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization;\n* 9\\) Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization, or any implant of any Cardiac Resynchronization Therapy (CRT-P) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD) within the last 30days prior to subject registration，or patients who meet the indications of CRT-P and CRT-D but are not implanted;\n* 10\\) In the judgment of the investigator, the subject's femoral vein is unable to accommodate a 22F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture;\n* 11)) Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated;\n* 12\\) End-stage heart failure (ACC\u002FAHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.；\n* 13\\) Active endocarditis; Or valvular degeneration caused by active rheumatic heart disease or rheumatic disease (such as poor compliance, perforation, etc)；\n* 14\\) Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication)；\n* 15\\) Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (\\> 70% by ultrasound), carotid artery stenting within 30 days.；Cerebrovascular accident (hemorrhagic) within 6 months；\n* 16\\) History of acute peptic ulcer or gastrointestinal bleeding within 3 months；\n* 17)Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication；\n* 18\\) Modified Rankin Scale ≥4.；\n* 19\\) The subjects suffer from diseases that may lead to difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.)；\n* 20）Pregnant or breastfeeding women, or women who plan to become pregnant within the next 12 months.\n\nNote: Women of childbearing age should take a pregnancy test with a negative result within 14 days prior to registration and use scientifically safe contraception；\n\n* 21\\) Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or an intra-aortic balloon pump；\n* 22\\) Active infections requiring antibiotic therapy (in the case of temporary illness, antibiotics must be discontinued for at least 14 days before the subject can be enrolled).；\n* 23\\) Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials；\n* 24\\) In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.",{"count":261,"type":20},140,[23],"To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.",[28],[266,30],"Heart Valve Disease","2022-08-17",{"date":269,"type":43},"2022-08-19",{"date":271,"type":20},"2022-08-30",{"date":273,"type":20},"2027-12-30",{"name":275,"class":126},"Pan Xiangbin",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":286,"studyType":107,"phases":4,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":252},"100377136","multicenter-post-market-observational-registry-of-the-neochord-artificial-chordae-delivery-system-100377136","NCT04190602","Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System","The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System","AcChord","Inclusion Criteria:\n\n* Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation\n* Study procedure completed after 31 December 2016\n\nExclusion Criteria:\n\n* Heavily calcified valves\n* Valvular retraction with severely reduced mobility\n* Active bacterial endocarditis\n* Complex mechanism of MR (leaflet perforation, etc.)\n* Significant tethering of leaflets\n* Inflammatory valve disease",{"count":285,"type":20},500,"5 Years","The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.",[65,186,28,112,31],[290,291,292,293],"NeoChord","DS1000","Artificial Chordae","Mitral Valve Repair","2020-07-09",{"date":296,"type":43},"2020-07-10",{"date":298,"type":43},"2020-02-09",{"date":300,"type":20},"2027-12",{"name":290,"class":50},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":97},"100321850","personalized-activity-intervention-in-rehabilitation-after-cardiac-operations-the-paco-trial-100321850","NCT03470246","Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)","Personalized Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in Rehabilitation After Cardiac Operations (the PACO Trial)","PACO","Inclusion Criteria:\n\n* An eligible patient with coronary artery disease, aortic valve stenosis or mitral valve insufficiency scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair operation.\n* He \u002F she does not have any severe disease or functional limitation limiting PA (other than CVD).\n* He \u002F she is willing to wear a hip- and wrist-worn accelerometer.\n* He \u002F she is willing and capable to use a smart phone application.\n\nExclusion Criteria:\n\n* He \u002F she ends up in prolonged intensive care after cardiac operation.\n* He \u002F she has a memory disorder (i.e. Alzheimer's disease).","30 Years","90 Years",{"count":313,"type":20},540,[23],"The PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either intervention or control group. The specific operation groups (CABG, AVR and MVR) will be analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer during the pre-operative month.\n\nAfter the cardiac procedure is completed and the patient is moved to post-operative ward, the control group patients will begin the standard post-operative rehabilitation program of the participating hospitals (activity guidance given by a physiotherapist). Patients in the intervention groups will follow the identical program but after discharge they will also receive personalized activity guidance through the combination of ExSed smart phone application, Suunto MoveSense accelerometer and cloud system during the first 90 days of post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for each patient of the intervention groups. A new daily step goal will be delivered from the cloud system to the patient's smart phone in the beginning of each week of the intervention. The daily step goal of the first intervention week is based on patient's walking distance assessed by a physiotherapist in post-operative ward. The following goals will be automatically evolved in the basis of patient's personal average step count of the previous week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and transmit the data to user's ExSed application with Bluetooth. With information about accumulated levels of SB and PA, the application is able to guide the patient to accomplish the predefined activity goal. The guidance and motivation will be offered with pop-up notifications and histograms (columns are fulfilled according to patient's accumulated daily activity). The researches retain a remote access to the activity data of patients in the cloud system. The ExSed application will be connected to the cloud system with internet connection.\n\nIn addition, the patients of the intervention groups will receive short video files (lasting from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to cardiac operation patients. These videos are available on the ExSed application during the intervention. The physiotherapist will also contact each patient (by mobile phone) with structured contact form from 1 to 4 times in a month to make sure that the intervention is proceeding as designed.",[317,110,28],"Coronary Artery Disease",[319,320,321,322,323,324,325,326,327,328],"Accelerometer","Aortic valve replacement","Aortic valve stenosis","Coronary artery bypass grafting","Coronary artery disease","eHealth","Interactive guidance","Mitral valve insufficiency","Mitral valve repair","Rehabilitation","2019-08-14",{"date":331,"type":43},"2019-08-15",{"date":333,"type":43},"2018-04-06",{"date":335,"type":20},"2028-03-01",{"name":337,"class":126},"Kuopio University Hospital"]