Clinical Trial

Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement

Study acronym: DURABLE-Mitral
Enrolling by Invitation
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Record status
This record was last updated September 3, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
It aims to perform a retrospective, multi-center, observational study. All patients undergoing elective mitral valve replacement from 2012 to 2021 who met the inclusion criteria for the study (described in the dedicated section) will be enrolled in the study. These patients will be followed-up as part of routine care, and information about the clinical status, NYHA functional class, possible rehospitalization, possible cardiovascular events and postoperative echocardiography will be available for analysis. Once consent is given, and if required by local governance, pre-, intra- and post-operative data will be collected in a dedicated, structured, database.
Trial Details
NCT Number NCT07151989
Lead Sponsor Maastricht University Medical Center
Conditions Degeneration Mitral Bioprosthesis
Enrollment 3,500 participants
Start Date 2024-01-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-03