Mitral Prosthetic Valve Stenosis and Regurgitation Clinical Trial
Official title:
Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction
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.
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve
versus redo surgical mitral valve replacement.
After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be
randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement
(TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement
with 3 commercially available surgical bioprosthetic valves. A sub-randomization in the
surgical group will define which bioprosthetic valve will be used. Patients will be seen for
follow-up visits at discharge, 30 days, 6 months and annually through 10 years.
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