[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640284":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":10,"responsibleParty":34,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":10},{"fullName":5,"class":6},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Concomitant isolated MR - 3+ or 4",null,"Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER).",{"label":13,"type":10,"description":14,"interventionNames":10},"Concomitant isolated TR - 3+ to 5","Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER).",{"label":16,"type":10,"description":17,"interventionNames":10},"Concomitant MR and TR","Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.",[19],{"name":20,"affiliation":21,"role":22},"Josep Rodes Cabau, MD PhD","IUCPQ-UL","PRINCIPAL_INVESTIGATOR",[24,29],{"name":20,"role":25,"phone":26,"phoneExt":27,"email":28},"CONTACT","14186568711","5593","josep.rodes@criucpq.ulaval.ca",{"name":30,"role":25,"phone":31,"phoneExt":32,"email":33},"Melanie Côté, MSc","4186568711","2646","melanie.cote@criucpq.ulaval.ca",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Josep Rodes-Cabau","Cardiologist","100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284",false,"NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.","ALL","18 Years",{"count":49,"type":50},300,"ESTIMATED","OBSERVATIONAL","Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[54,55,56,57],"Aortic Stenosis","Mitral Regurgitation","Tricuspid Regurgitation","Transcatheter Aortic Valve Implantation (TAVI)",[59,60,61,62,63,64,65],"Aortic stenosis","Transcatheter aortic valve implantation (TAVI)","Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","NOT_YET_RECRUITING","2026-05-28",{"date":69,"type":70},"2026-06-03","ACTUAL",{"date":72,"type":50},"2026-06-05",{"date":74,"type":50},"2034-06-05",{"name":36,"class":6}]