[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-mitral-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-mitral-regurgitation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,78,104,126,147,168,191,215],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100510006","atrial-functional-mitral-regurgitation-and-tricuspid-regurgitation-100510006",false,"NCT05920824","Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation","Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation","Inclusion Criteria:\n\n* Informed consent\n* Age of 18 years or older\n* Atrial fibrillation\n* Moderate or severe atrial valve disease\n* Adequate 2D echocardiography views including parasternal long axis, short axis, apical two chamber, apical three chamber and four chamber.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Left ventricular impairment (ejection fraction \\\u003C 50%).\n* Primary\u002Forganic valve disease","ALL","18 Years",{"count":19,"type":20},141,"ESTIMATED","1 Year","OBSERVATIONAL","A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \\& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation.\n\nParticipant will under go:\n\n* Baseline echocardiography\n* Cpex Echocardiography\n* Blood test: BNP\n* 1 year follow up Echocardiography\n\nParticipants will be stratified into three subgroups:\n\n* Atrial Functional MR\n* Atrial Functional TR\n* Mixed MR \\& TR",[25,26,27],"Atrial Fibrillation","Functional Mitral Regurgitation","Functional Tricuspid Regurgitation","RECRUITING","2026-04-20",{"date":31,"type":32},"2026-04-21","ACTUAL",{"date":34,"type":32},"2023-08-23",{"date":36,"type":20},"2027-08",{"name":38,"class":39},"Barts & The London NHS Trust","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100296681","the-empower-trial---the-carillon-mitral-contour-system-in-treating-heart-failure-with-fmr-100296681","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",{"count":49,"type":20},300,"INTERVENTIONAL",[52],"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).",[26,55,56,57,58,59],"Heart Failure","Mitral Valve Insufficiency","Heart Diseases","Cardiovascular Diseases","Heart Valve Diseases",[26,61,62,63,64,65,66],"Percutaneous Mitral Valve Repair","Percutaneous Mitral Valve Annuloplasty","Coronary Sinus Annuloplasty","Secondary Mitral Regurgitation","Functional MR","FMR","2026-04-08",{"date":69,"type":32},"2026-04-13",{"date":71,"type":32},"2018-01-01",{"date":73,"type":20},"2030-12-31",{"name":75,"class":76},"Cardiac Dimensions, Inc.","INDUSTRY",92,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100603062","secondary-mitral-regurgitation-treatment-with-mitraclip-and-assessment-by-cardiac-magnetic-resonance-100603062","NCT07131631","Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance","SMARTER-CMR","Inclusion Criteria:\n\n1\\. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF \\\u003C 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)\n\nExclusion Criteria:\n\n1. Concomitant PCI and TEER\n2. Congenital heart disease\n3. Stage D heart failure\n4. Uncontrolled atrial fibrillation\n5. Pregnancy\n6. \\> moderate tricuspid regurgitation\n7. \\>moderate aortic regurgitation or stenosis\n8. Contraindications or unable to undergo CMR\n9. Prior mitral valve repair or replacement",{"count":86,"type":20},125,"This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.",[89,26],"Heart Failure and Reduced Ejection Fraction",[91,92,93],"heart failure","reduced ejection fraction","functional mitral regurgitation","2025-12-16",{"date":96,"type":32},"2025-12-23",{"date":98,"type":32},"2022-03-03",{"date":100,"type":20},"2027-07",{"name":102,"class":39},"Minneapolis Heart Institute Foundation",6,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":40},"100513422","phenotypic-classification-of-fmr-with-cmr-100513422","NCT05965258","Phenotypic Classification of FMR With CMR","Improving Phenotypic Classification and Prediction of Treatment Outcomes in Patients With Non-ischemic Cardiomyopathy and Functional Mitral Regurgitation","Inclusion Criteria:\n\n1 CMR LVEF \\\u003C55% 2.FMR Fraction\\>20% or echo criteria consistent with at least moderate mitral regurgitation with adequate image quality\n\nExclusion Criteria:\n\n1. \\>moderate aortic regurgitation\u002Fstenosis,\n2. \\\u003C18 years of age,\n3. acute myocarditis,\n4. eGFR\\\u003C15\n5. HCM\n6. cardiac amyloidosis\u002Fsarcoidosis\n7. prior mitral valve intervention\n8. myocardial infarction within 8 weeks of CMR",{"count":112,"type":20},360,"The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR.\n\nThe prospective study entails aiming to recruit 360 adult patients (ages \\>18 years) with EF 10-50% and FMR RF\\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.",[115,26,116],"Nonischemic Congestive Cardiomyopathy","Ischemic Cardiomyopathy","2025-10-17",{"date":119,"type":32},"2025-10-20",{"date":121,"type":32},"2023-08-29",{"date":123,"type":20},"2028-12-31",{"name":125,"class":39},"The Cleveland Clinic",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":50,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100560955","bio-refine-for-functional-mitral-regurgitation---a-safety--feasibility-study-100560955","NCT06583876","Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study","Inclusion Criteria:\n\n* Local heart team has determined that mitral valve surgery will not be offered as a treatment option\n* Symptomatic secondary mitral regurgitation (3+ or 4+)\n* Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days\n* NYHA functional class II, III or ambulatory IV\n* LVEF ≥30%.\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* CABG, PCI or TAVR within the prior 90 days.\n* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation.\n* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.\n* CVA or TIA within prior 180 days.\n* Hypotension\n* Any history of ventricular arrythmia\n* Patients implanted with any kind of CIED\n* Life expectancy \\\u003C12 months due to non-cardiac conditions\n* Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure\n* TEE is contraindicated or high risk\n* Pregnant or planning pregnancy within next 12 months\n* Currently participating in an investigational drug or another device study that has not reached its primary endpoint",{"count":133,"type":20},15,[52],"The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation.\n\nThe study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and\u002For will not be offered as a treatment option (the risk is prohibitive).\n\nPotential patients will be screened to confirm that all inclusion\u002Fexclusion criteria are met, with final eligibility confirmation on day of procedure.\n\nAll enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.\n\nAdditional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.",[26],"2025-03-26",{"date":139,"type":32},"2025-03-27",{"date":141,"type":32},"2024-06-03",{"date":143,"type":20},"2027-02",{"name":145,"class":76},"Bio Refine Ltd.",4,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":50,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":40},"100579392","safety-and-effectiveness-study-of-sq-kyrin-system-for-functional-mitral-regurgitation-in-eu-100579392","NCT06823700","Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU","A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation","Inclusion Criteria:\n\n1. Participant who has provided written informed consent for the investigation.\n2. Age ≥18 years.\n3. Patients diagnosed with FMR.\n4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).\n5. LVEF ≥20% to ≤60%.\n6. Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.\n7. According to the judgment of local cardiology team, subjects have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.\n8. Subject fulfils FMR anatomy selection criteria.\n9. According to the judgment of the local Cardiovascular medical-surgery team, subjects who have high or prohibitive risk for open heart surgery.\n10. Left ventricular end-systolic diameter (LVESD)≤70mm.\n11. The MR beam mainly originates from the A2\u002FP2 area.\n12. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\\>10mm.\n13. Mitral valve effective orifice area (EOA) ≥ 4.0cm2.\n14. No obvious calcification of main grasp mitral valve leaflets.\n15. Patient anatomy allows atrial septum approach.\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.\n2. Hypotension (systolic pressure \\\u003C90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.\n3. UNOS status 1 heart transplantation or prior orthotopic heart transplantation.\n4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n5. Fixed pulmonary artery systolic pressure \\>70 mm Hg.\n6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.\n7. Mitral valve anatomy which may preclude proper device treatment.\n8. Mitral valve area \\\u003C 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).\n9. Any prior mitral valve surgery or transcatheter mitral valve procedure.\n10. Stroke or transient ischemic event within 30 days before enrolment.\n11. Modified Rankin ≥ Scale 4 disability.\n12. Severe symptomatic carotid stenosis (\\>70% by ultrasound).\n13. Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.\n14. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.\n15. Untreated clinically significant coronary artery disease requiring revascularization.\n16. Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days\n17. Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.\n18. Aortic valve disease requiring intervention or any concomitant treatment.\n19. Need for any cardiovascular intervention (other than for MV disease).\n20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n21. Active endocarditis.\n22. Active infections requiring current antibiotic therapy.\n23. Subjects in whom transoesophageal echocardiography is contraindicated or high risk.\n24. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.\n25. Patient unable or unwilling to provide written, informed consent before study enrolment.\n26. Pregnant woman or woman planning to become pregnant.\n27. Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.\n28. Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.",{"count":155,"type":20},34,[52],"The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.",[26],"2025-02-08",{"date":161,"type":32},"2025-02-12",{"date":163,"type":32},"2024-12-17",{"date":165,"type":20},"2026-12-31",{"name":167,"class":76},"Shanghai Shenqi Medical Technology Co., Ltd",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":50,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":40},"100578662","cap-teer-cerebral-protection-during-transcatheter-edge-to-edge-repair-100578662","NCT06814210","CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair","Inclusion Criteria:\n\nSubjects must meet ALL of the following criteria:\n\nGeneral Inclusion Criteria\n\n* Age ≥18 years\n* Severe Mitral Regurgitation (3+ to 4+)\n* Symptom status: NYHA functional class ≥ II\n* Subjects scheduled to receive the M-TEER per the current approved indications for use\n* Subjects agreed to join the study and complete follow-up\n\nExclusion Criteria:\n\nPotential Subjects will be excluded if ANY of the following criteria apply:\n\nGeneral Exclusion Criteria\n\n* Contraindication to MRI\n* CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days\n* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention\n* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n* Cerebrovascular accident within prior 30 days\n* Severe symptomatic carotid stenosis (\\>70% by ultrasound)\n* Carotid surgery or stenting within prior 30 days\n* Hemodynamic instability requiring inotropic support or mechanical heart assistance\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Contraindication for transesophageal echocardiography\n* Life expectancy \\\u003C 1 year\n* Pregnant or planning pregnancy within next 12 months\n* Participation in another interventional Trial\n* Patients who are not able to give consent or complete the follow-up",{"count":175,"type":20},120,[52],"Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.\n\nThis prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.",[179,26,180],"Mitral Regurgitation","Degenerative Mitral Valve Regurgitation","NOT_YET_RECRUITING","2025-02-05",{"date":184,"type":32},"2025-02-07",{"date":186,"type":20},"2025-03-01",{"date":188,"type":20},"2025-10-31",{"name":190,"class":39},"Xiao-dong Zhuang",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":50,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":40},"100392927","epicardial-mitral-touch-system-for-mitral-insufficiency-100392927","NCT04396379","Epicardial Mitral Touch System for Mitral Insufficiency","ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency","ENRAPTUS","Inclusion Criteria:\n\n* Moderate or greater (2+) ischemic\n* Functional Mitral regurgitation by 2D echocardiography using an integrative method\n* Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)\n* Patient is 22 years of age or older\n* Patient is willing and able to sign Informed Consent Form\n* Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States\n\nExclusion Criteria:\n\n* Any evidence of structural (chordal or leaflet) mitral valve disease\n* Inability to derive ERO, LVESVI or LVEDVI by TTE\n* Prior surgical or percutaneous mitral valve intervention\n* Contraindication to cardiopulmonary bypass (CPB)\n* Clinical signs of cardiogenic shock\n* Treatment with chronic intravenous inotropic therapy\n* Severe, irreversible pulmonary hypertension in the judgement of the investigator\n* ST segment elevation requiring intervention within 7 days prior to randomization\n* Congenital heart disease (except PFO or ASD)\n* Evidence of cirrhosis or hepatic synthetic failure\n* Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin)\n* History of endocarditis or current endocarditis\n* Ejection fraction \\\u003C25%\n* NY heart class IV\n* MV diameters \\> 7cm\n* Any coronary artery calcification at site of placement as determined by angiogram\n* Myxomatous mitral regurgitation\n* Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)\n* Abnormal cardiac anatomy discovered prior to surgery or during procedure\n* Pericardial adhesions\n* Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)","22 Years",{"count":201,"type":20},10,[52],"To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.",[205,26],"Ischemic Mitral Regurgitation","2023-01-02",{"date":208,"type":32},"2023-01-04",{"date":210,"type":20},"2023-09-10",{"date":212,"type":20},"2027-12-31",{"name":214,"class":76},"Mitre Medical Corp.",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":50,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100414676","explore-fmr-early-feasibility-study-of-the-plar-implant-and-delivery-system-to-treat-functional-mitral-regurgitation-100414676","NCT04679714","EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation","Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation (EXPLORE FMR)","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Greater than moderate functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure\n3. Patient must present with an STS Score less than 10%\n4. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure\n5. New York Heart Association (NYHA) Functional Class III or IV\n6. Patient willing to participate in study and provide signed IRB\u002FEC-approved informed consent\n7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Severe tricuspid regurgitation\n2. Severe aortic stenosis or insufficiency\n3. Severe mitral annulus calcification\n4. Diseased mitral anterior leaflet such as flail \u002F prolapse\u002F heavy calcification\n5. Implanted vena cava filter\n6. Femoral veins with severe angulation and calcification\n7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan\n8. Active infection or endocarditis\n9. Previous mitral valve surgery\n10. Prior orthotopic heart transplantation\n11. Pulmonary artery systolic hypertension \\> 70mmHg\n12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus\n13. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n14. Implant or revision of any pacing device \\\u003C 30 days prior to intervention\n15. Symptomatic coronary artery disease treated \\\u003C 30 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 renal insufficiency (creatinine \\> 3.0 mg\u002FdL) or patient requiring dialysis\n21. Cardiogenic shock at time of enrolment\n22. Hemodynamic instability requiring inotropic support or mechanical heart assistance\n23. Concurrent medical condition with a life expectancy of less than 2 years\n24. Pregnancy at time of enrolment\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\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. Emergency situations\n29. Company employees or their immediate family members\n30. Patient is under guardianship\n31. Patient is participating in another clinical study for which follow-up is currently ongoing",{"count":201,"type":20},[52],"An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.",[26],"2020-12-21",{"date":228,"type":32},"2020-12-22",{"date":230,"type":20},"2021-03",{"date":232,"type":20},"2026-12",{"name":234,"class":76},"Polares Medical SA"]