NCT04402931

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

Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Instituto Dante Pazzanese de Cardiologia · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Mitral Prosthetic Valve Stenosis and Regurgitation

Interventions

Type	Name	Description
PROCEDURE	Transcatheter Valve-in-Valve Intervention	Transcatheter mitral valve-in-valve implantation with SAPIEN 3
PROCEDURE	Redo Mitral valve surgery	Transcatheter Valve-in-Valve Intervention

Timeline

• Start date: 2020-02-17
• Primary completion: 2024-02-01
• Completion: 2025-08-01
• First posted: 2020-05-27
• Last updated: 2025-09-04

Locations

7 sites across 1 country: Brazil