Clinical Trial

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

Study acronym: DURABLE-TRIC
Enrolling by Invitation
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Summary
The structural deterioration process of the implanted bioprosthesis in tricuspid position for tricuspid valve pathology is gradual and irreversible and includes many changes, such as pannus growth, leaflet fibrosis and calcification, delamination of the connective tissue, ruptures and perforations of leaflets. In the great majority of cases SVD consists of leaflet calcium deposits and can be clinically associated with young age, hypercholesterolemia, hypertension, diabetes mellitus, renal failure. The long term durability of these bioprosthesis is still missing.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-07.
Trial Details
NCT Number NCT06875154
Lead Sponsor Maastricht University Medical Center
Conditions Degeneration of Tricuspid Surgical Bioprosthesis
Enrollment 500 participants
Start Date 2024-06-01
Primary Completion 2025-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-04