Status:
COMPLETED
The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Mitral Valve Disease
Mitral Regurgitation
Eligibility:
All Genders
18-80 years
Brief Summary
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse e...
Detailed Description
Patients with mitral valve insufficiency frequently suffer from left atrial remodeling, caused by volume overload and subsequent atrial dilatation. The associated myocardial stretch and increased wall...
Eligibility Criteria
Inclusion
- Patients that meet the criteria for elective mitral valve repair surgery according to the European clinical guidelines (class I recommendation);
- Symptomatic, chronic severe mitral valve insufficiency due to degenerative valve disease with a left ventricular ejection fraction \>30%.
- Asymptomatic, chronic severe mitral valve insufficiency due to degenerative valve disease with a left ventricular ejection fraction \<60% and/or a left ventricular end-systolic diameter \>45 mm.
Exclusion
- not able to provide written informed consent.
- under the age of 18.
- with a history of cardiac surgery
- with atrial fibrillation
- with any comorbidity besides mitral valve insufficiency.
- with claustrophobia or any other contra-indication for magnetic resonance imaging
Key Trial Info
Start Date :
February 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05345730
Start Date
February 2 2022
End Date
December 31 2023
Last Update
July 5 2024
Active Locations (1)
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1
AmsterdamUMC
Amsterdam, North Holland, Netherlands, 1105 AZ