Status:
ENROLLING_BY_INVITATION
Influence of Original Native Tricuspid Valve Lesion (Stenosis or Steno-insufficiency or Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Tricuspid Valve Replacement.
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Degeneration of Tricuspid Surgical Bioprosthesis
Eligibility:
All Genders
18+ years
Brief 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, le...
Detailed Description
It is not clear if the same biochemical, hemodynamic and immunological mechanisms leading to native valve calcification can cause bioprosthetic SVD. We hypothesize that the mechanisms protecting the n...
Eligibility Criteria
Inclusion
- \- Age ≥ 18 years; 6
- \- Patients who underwent isolated tricuspid valve replacement for stenosis, regurgitation or steno-regurgitation
- \- Signed informed consent, inclusive of release of medical information where required by local governance.
Exclusion
- Tricuspid valve replacement associated with other surgical procedures (CABG or other)
- Previous cardiac surgery of any kind;
- \- Surgery for acute endocarditis
- \- Participation in another clinical trial that could interfere with the endpoints of this study.
- \- Pregnant or breastfeeding at time of screening.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06875154
Start Date
June 1 2024
End Date
January 1 2026
Last Update
May 4 2025
Active Locations (1)
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1
Cardio-Thoracic Surgery Department - Heart & Vascular Centre - Maastricht University Medical Centre (MUMC+)
Maastricht, Netherlands