Status:
ENROLLING_BY_INVITATION
Influence of Original Native Mitral Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Mitral Valve Replacement
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Degeneration Mitral Bioprosthesis
Eligibility:
All Genders
18+ years
Brief 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 (describ...
Detailed Description
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 (describ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Patients who underwent isolated mitral valve replacement for stenosis or regurgitation
- Signed informed consent, inclusive of release of medical information where required by local governance.
Exclusion
- \- Aortic and mitral valve replacement associated with surgery of ascending aorta/aortic root;
- Aortic and mitral valve replacement associated with other cardiac valve surgery (apart from arrythmia-related ablation or procedures);
- Previous cardiac surgery of any kind;
- Surgery for acute endocarditis
- Surgery for Type A aortic dissection
- 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 :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT07151989
Start Date
January 1 2024
End Date
May 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
Maastricht UMC+
Maastricht, Maastricht, Netherlands