CompletedNot Applicable

Randomized Trial of Transcatheter Valve-in-Valve vs Redo Surgery for Bioprosthetic Mitral Dysfunction

Brazil150 participantsStarted 2020-02-17

Plain-language summary

Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. Studies of cost-effectiveness and cost-utility comparing both strategies were also not reported. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.

Who can participate

Age range70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age\>18 years; * Symptoms of heart failure NYHA class\>ll; * Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography; * Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate; * The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center; * The study patient agreed to comply with all required post- procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up; * Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present); * Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment. Exclusion Criteria: * Heart Team assessment of inoperability (including examining cardiac surgeon); * Hostile chest; * Evidence of an acute myocardial infarction \< 1 month (30 days) before the intended treatment \[defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)\]; * Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring s…

What they're measuring

Rate of Major cardiovascular and Cerebrovascular events

Timeframe: 12 months

Trial details

NCT IDNCT04402931

SponsorInstituto Dante Pazzanese de Cardiologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01