[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-regurgitation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,74,118,142,174,205,228,249,274],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100304396","transcatheter-mitral-valve-replacement-with-the-medtronic-intrepid-tmvr-system-in-patients-with-severe-symptomatic-mitral-regurgitation-100304396",false,"NCT03242642","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.","Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial","APOLLO","Inclusion Criteria:\n\n* Moderate to severe or severe symptomatic mitral regurgitation\n* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention\n\nExclusion Criteria:\n\n* prior transcatheter mitral valve procedure with device currently implanted\n* anatomic contraindications\n* prohibitive mitral annular calcification\n* left ventricular ejection fraction \\\u003C25%\n* need for emergent or urgent surgery\n* hemodynamic instability","ALL","18 Years",{"count":20,"type":21},1056,"ESTIMATED","INTERVENTIONAL",[24],"NA","Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.",[27],"Mitral Valve Regurgitation",[29,30,31,32,33,34],"Heart disease","valve disease","heart valve disease","mitral regurgitation","cardiovascular disease","mitral insufficiency","RECRUITING","2026-06-26",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2017-10-23",{"date":43,"type":21},"2036-09-30",{"name":45,"class":46},"Medtronic Cardiovascular","INDUSTRY",85,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100227999","stsacc-tvt-registry-mitral-module-100227999","NCT02245763","STS\u002FACC TVT Registry Mitral Module","The Society of Thoracic Surgeons\u002F American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module","TMVR","Inclusion Criteria:\n\n* All patients\n\nExclusion Criteria:\n\n* Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen\n* Active endocarditis of the mitral valve\n* Rheumatic mitral valve disease\n* Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus",true,"1 Year",{"count":59,"type":21},4000,"OBSERVATIONAL","The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of mitral valve disease.",[27],"2026-06-12",{"date":65,"type":39},"2026-06-15",{"date":67,"type":4},"2013-11",{"date":69,"type":21},"2030-12-31",{"name":71,"class":72},"American College of Cardiology","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":73},"100632974","impact-of-transcatheter-aortic-valve-implantation-and-mitral-valve-repair-on-sleep-disordered-breathing-100632974","NCT07520656","Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing","Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing","SLEEP-VALVE","Inclusion Criteria:\n\n* Adult patients undergoing TAVI or M-TEER\n* Ability to undergo polysomnography\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Inability to undergo sleep study (polysomnography)\n* Inability to complete follow-up at 6 months\n* Cognitive impairment (e.g., dementia)\n* Refusal to participate",{"count":83,"type":21},150,"This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients with significant valvular heart disease. Patients undergoing TAVI or M-TEER will be evaluated with full polysomnography prior to the intervention and at 6 months follow-up. Changes in sleep parameters, including apnea-hypopnea index (AHI), central and obstructive apnea indices, oxygen desaturation, and sleep architecture, will be assessed. In addition, the study will explore the association between changes in SDB and echocardiographic as well as arrhythmic parameters. The findings are expected to improve the understanding of the interaction between valvular heart disease and SDB and to identify potential benefits of transcatheter interventions on sleep-related outcomes.",[86,87,27],"Sleep-disordered Breathing (SDB)","Aortic Valve Stenosis",[89,90,91,92,93,94,32,95,96,97,98,99,100,101,102,103,104,105,106,107,108],"tavi","m-teer","sleep apnea","sleep disordered breathing","aortic stenosis","aortic valve","AS","MR","mitral valve","transcatheter","sdb","sleep-disordered breathing","obstructive sleep apnea","osa","central sleep apnea","csa","transcatheter aortic valve implantation","mitral valve repair","MitraClip","valvular heart disease","2026-04-02",{"date":111,"type":39},"2026-04-09",{"date":113,"type":39},"2025-07-20",{"date":115,"type":21},"2029-09-01",{"name":117,"class":72},"Aristides Plaitis",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":60,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":73},"100615700","the-asia-pacific-mitral--tricuspid-valve-in-valvevalve-in-ring-registry-100615700","NCT07296016","The Asia-Pacific Mitral & Tricuspid Valve-in-Valve\u002FValve-in-Ring Registry","AP ViV","Inclusion Criteria:\n\n1. Age ≥ 21\n2. Had at least one documented Mitral valve-in-valve\u002Fvalve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve\u002Fvalve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve\u002Fvalve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve\u002Fvalve-in-ring procedure. (Prospective)\n\nExclusion Criteria:\n\n1. Active endocarditis\n2. Any other conditions which investigator deems unsuitable for participation.","21 Years",{"count":127,"type":21},15,"10 Years","A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic\u002Fmechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.",[131,27],"Structural Heart Disease","NOT_YET_RECRUITING","2025-12-16",{"date":135,"type":39},"2025-12-22",{"date":137,"type":21},"2026-01-05",{"date":139,"type":21},"2035-12-31",{"name":141,"class":72},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":152,"conditions":153,"keywords":159,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100577973","left-ventricular-reverse-remodeling-evaluation-after-surgical-correction-of-aortic-regurgitation-100577973","NCT06805253","Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation","Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment","ORMIX","Inclusion Criteria:\n\n* Age over 18 years\n* Planned primary elective surgery for chronic aortic regurgitation\n* Presence of functional mitral regurgitation\n* End-diastolic volume of the left ventricle \\>= 250 ml\n\nExclusion Criteria:\n\n* Infectious endocarditis\n* History of myocardial infarction\n* Indications on simultaneous myocardial revascularisation\n* Acute aortic regurgitation of any etiology\n* Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation\n* Long-term persistent or permanent form of atrial fibrillation\n* Pregnancy in the first 12 months after surgery\n* Simultaneous participation in other studies\n* Presence of implanted pacemakers\n* Refusal to sign informed consent\n* Acute coronary event diagnosed within 12 months after aortic valve surgery\n* Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery\n* Re-do cardiac surgery for any reason within 12 months after aortic valve surgery",{"count":151,"type":21},120,"Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.",[154,27,155,156,157,158],"Aortic Valve Regurgitation","Left Ventricle Dilated","Left Atrium Dilated","Systolic Left Ventricular Heart Failure","Diastolic Heart Failure",[160,161,162,163],"reverse remodeling","left ventricle dilatation","mitral valve functional regurgitation recovery","left ventricle reverse remodeling","2025-06-05",{"date":166,"type":39},"2025-06-11",{"date":168,"type":39},"2024-05-09",{"date":170,"type":21},"2030-05",{"name":172,"class":72},"Petrovsky National Research Centre of Surgery",2,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":189,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100551873","altavalve-pivotal-trial-100551873","NCT06465745","AltaValve Pivotal Trial","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 index procedure.\n* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.",{"count":181,"type":21},450,[24],"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.",[185,186,187,27,188],"Mitral Regurgitation","Mitral Insufficiency","Mitral Valve Incompetence","Mitral Incompetence",[185,54,190,191,192,193,194],"Functional Regurgitation","Degenerative Regurgitation","Transcatheter Mitral Valve Replacement","Primary Regurgitation","Secondary Regurgitation","2025-04-30",{"date":197,"type":39},"2025-05-02",{"date":199,"type":39},"2024-09-03",{"date":201,"type":21},"2031-09",{"name":203,"class":46},"4C Medical Technologies, Inc.",29,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100377550","mi-thos-transcatheter-mitral-valve-replacement-study-100377550","NCT04195984","Mi-thos® Transcatheter Mitral Valve Replacement Study","Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.","Inclusion Criteria:\n\n* Severe mitral valve regurgitation ≥ 3+;\n* High surgical risk fot open mitral valve surgery;\n* Age ≥ 65 years old;\n* Life expectancy \\> 12 months;\n* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;\n* Patients sign an informed consent form.\n\nExclusion Criteria:\n\n* Previous cardiac mitral valve surgery;\n* Active infections requiring antibiotic therapy;\n* Clinically significant untreated Coronary Artery Disease (CAD);\n* Pulmonary hypertension （Pulmonary systolic pressure \\> 70 mmHg）;\n* Patients with severe right heart failure;\n* Left ventricular ejection fraction \\\u003C25%;\n* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;\n* Dialysis patient;\n* Patients with severe coagulopathy;\n* Patients with contraindications to anticoagulant drugs;\n* Patients with stroke or transient ischemic within 30 days;\n* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;\n* Patients who require surgery or interventional therapy for other valvular lesions;\n* Patients with severe macrovascular disease requiring surgical treatment;\n* Patients with more than 70% of carotid stenosis;\n* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;\n* Patients with severe neurological disorders affecting cognitive ability;\n* Patients with severe thoracic deformities.","65 Years",{"count":214,"type":21},122,[24],"To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.",[27],"2025-02-11",{"date":220,"type":39},"2025-02-13",{"date":222,"type":39},"2021-03-25",{"date":224,"type":21},"2027-01",{"name":226,"class":46},"Shanghai NewMed Medical Co., Ltd.",3,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":237,"studyType":60,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":73},"100474252","gise-registry-of-transcatheter-treatment-of-mitral-valve-regurgitation-with-the-mitraclip-g4-100474252","NCT05455489","GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","Inclusion Criteria:\n\nSUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy AND\n\n* Left Ventricular End-Systolic Dimension \\\u003C70 mm\n* Mitral Valve area \\> 4 cmq\n* Left ventricular ejection fraction ≥20%\n* NYHA functional class II, III, ambulatory IV\n* brain natriuretic peptide BNP ≥300 pg\u002Fml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg\u002Fml and\u002For at least one hosp for HF (Heart failure) in the 12 months prior to enrollment\n* Age 18 years or older\n* Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF\n* Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND\n* Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device\n* MV area \\> 4 cm2\n* NYHA functional class \\> II\n* Age 18 years or older\n* Local HT decision In case of patients with a coexistence of both etiologies, they will be assigned to a subgroup based on the prevailing mechanism.\n\nTHE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from the criteria recommended by the American Society of Echocardiography 2003 Guidelines and based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR was 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them. For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on the integrative evaluation of multiple parameters recommended by the The American Society of Echocardiography (ASE)\n\nExclusion Criteria:\n\n* Significant right ventricular disfunction (TAPSE\\\u003C15 mm and\u002For S'\\\u003C8cm\u002Fs)\n* Systolic pulmonary artery \\> 70 mmHg with irreversible precapillary pulmonary hypertension\n* Severe TR Tricuspid valve regurgitation\n* Hemodynamic instability\u002FNYHA IV\n* Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia\n* Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies\n* CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days\n* Life expectancy \\\u003C12 months due to non-cardiac conditions\n* Active infections\n* Advanced HF (ESC\u002FHFA Heart Failure Association Criteria) or Bridge tp to HTx\u002FLVAD (left ventricular assist device)",{"count":236,"type":21},264,"5 Years","The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers (\"more-comers\") population with symptomatic severe mitral regurgitation undergoing\u002Fundergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.",[27],"2024-03-01",{"date":242,"type":39},"2024-03-04",{"date":244,"type":39},"2023-01-25",{"date":246,"type":21},"2029-08-01",{"name":248,"class":72},"Fondazione GISE Onlus",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":5},"100421998","first-in-human-clinical-study-for-treatment-of-severe-mitral-valve-insufficiency-with-epygon-transcatheter-mitral-valve-system-100421998","NCT04775108","First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System","First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System (MINERVA FIH)","Inclusion Criteria:\n\n1. Patients of age ≥ 60 years.\n2. Patients with primary or secondary severe symptomatic mitral valve regurgitation.\n3. Patients with severe, symptomatic mitral regurgitation and who have been evaluated by a multidisciplinary Heart Team and deemed to be ineligible for conventional valve surgery and not eligible for transcatheter repair.\n4. Patients with a left ventricular ejection fraction ≥ 30%.\n5. Patients in NYHA functional classes III to IV.\n6. Patients who have clearly accepted participation in this clinical study and who have signed the informed consent.\n7. Patients who are willing to accept and undergo all protocol related requirements.\n8. Patients not planning to transfer abroad.\n\nExclusion Criteria:\n\n\\- Clinical exclusion criteria (preoperative screening)\n\n1. Patients involved in other clinical assessments for drugs or devices that could interfere or alter the study endpoints.\n2. Patients with clinical\u002Fanatomical conditions unsuitable for a transapical surgical approach.\n3. Patients who have previously undergone implantation of a transcatheter aortic valve prosthesis.\n4. Patients with previous implantation of a mitral heart valve prosthesis.\n5. Patients with previous implantation of a mitral annuloplasty ring.\n6. Patients needing emergency or life-saving interventions.\n7. Patients with a heavily calcified mitral annulus and\u002For anterior mitral leaflet.\n8. Patients with active infection or endocarditis (suspect endocarditis included).\n9. Patients with echocardiographic evidence of intracardiac mass or thrombus.\n10. Patients which suffered an acute myocardial infarction within 30 days of the intended treatment (defined as: Q wave MI, or non-Q wave MI with elevation of CK-MB ≥ 3 times normal in the absence of pathological Q waves), if no assay for CK-MB was performed, elevation of CK level to \\>2 times normal without new Q waves, or elevated Troponin level is also considered a non-Q wave MI).\n11. Patients with an active peptic ulcer or upper GI bleeding within the prior 30 days.\n12. Patients with a documented allergy towards contrast media, and to any compound of the investigated medical device.\n13. Patients that have neurological disease severely affecting ambulation or day to day functioning.\n14. Patients with any stroke within the prior 30 days.\n15. Patients with senile dementia, according to the advice from a specialized neurologist.\n16. Patients in whom transesophageal echocardiography (TEE) is contraindicated since TEE is used for both preoperative screening and guidance during implant procedure.\n17. Patients who is unwilling or deemed by the Investigator to be unwilling to comply with the requirements of the protocol, or subject with a history of non-compliance.\n18. Patients unable to understand and sign the Informed Consent Form in absence of legal representative.\n19. Patients with a lack of capacity to consent.\n20. Patients unable to read and write.\n\n    \\- Echographic exclusion criteria (preoperative screening)\n21. Patients with left ventricular apex aneurysm;\n22. Patients with aorto-mitral angle \\\u003C120°;\n23. Patients with a systolic\u002Fdiastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.\n\n    \\- Computerized Tomographic (CT) exclusion criteria (preoperative screening)\n24. Patients with ventricular morphology (position of papillary muscles, ventricular wall hypertrophy) unsuitable with the study valve design;\n25. Patients with aorto-mitral angle \\\u003C120°;\n26. Patients with a systolic\u002Fdiastolic mitral valve area assessed as not compatible with the sizing policy matrix defined by the Sponsor.","60 Years",{"count":258,"type":21},40,[24],"The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.\n\nThe EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent.\n\nThe purpose of this trial is to assess the safety and feasibility of the Epygon™ Transcatheter mitral valve and the transapical delivery system, in adult patients with severe, symptomatic mitral regurgitation.",[27],[263,264],"Mitral regurgitation","Mitral valve replacement","2023-08-04",{"date":267,"type":39},"2023-08-07",{"date":269,"type":39},"2021-02-01",{"date":271,"type":21},"2029-12-31",{"name":273,"class":46},"Epygon",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":281,"enrollmentInfo":282,"targetDuration":237,"studyType":60,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":73},"100406809","the-prospecive-observational-munich-interventional-mitral-valve-registry-100406809","NCT04577248","The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry","OBSERV-MITRA","Inclusion Criteria:\n\n* Age above 18 years and consentable\n* Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis\n* Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient's inability to fully cooperate with the protocol","110 Years",{"count":283,"type":21},5000,"Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.",[27,286,287],"Mitral Valve Stenosis","Tricuspid Valve Regurgitation","2020-10-06",{"date":290,"type":39},"2020-10-08",{"date":292,"type":39},"2020-09-15",{"date":294,"type":21},"2031-01-01",{"name":296,"class":72},"Deutsches Herzzentrum Muenchen"]