Status:
ENROLLING_BY_INVITATION
Influence of Original Native Aortic Valve Lesion (Stenosis or Steno-insufficiency vs. Insufficiency) on Post-implant Structural Bioprosthetic Degeneration After Aortic Valve Replacement
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Aortic Bioprosthesis Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for th...
Detailed Description
All patients undergoing elective aortic valve replacement for stenotic aortic valve replacement or aortic valve regurgitation at our institution from 2012 to 2021 who met the inclusion criteria for th...
Eligibility Criteria
Inclusion
- \- Age ≥ 18 years; 9
- Patients who underwent isolated aortic and mitral valve replacement for stenosis or regurgitation
- Signed informed consent, inclusive of release of medical information.
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 :
January 1 2026
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06964035
Start Date
January 1 2024
End Date
January 1 2026
Last Update
May 15 2025
Active Locations (1)
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1
Maastricht UMC+ METC
Maastricht, Maastricht, Netherlands