Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 47
- Primary Endpoint
- Mitral insufficiency grade 2+ or more
Study Overview
Brief Summary
This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.
Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinically significant mitral insufficiency
- •patient underwent screening for TMVI
- •echocardiography data at baseline (and after TMVI, E2E and surgery)
- •follow-up of at least 30 days
Exclusion Criteria
- •- age under 18 years
Outcomes
Primary Outcomes
Mitral insufficiency grade 2+ or more
Time Frame: 12 months
Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Freedom from device-related complications
Time Frame: 30 days
Secondary Outcomes
- Combined all-cause mortality or rehospitalization for congestive heart failure(12 months)
- Rehospitalization for congestive heart failure(12 months)
- Unplanned mitral valve intervention(12 months)
- All-cause mortality(12 months)
- Cardiovascular mortality(12 months)
- Combined cardiovascular mortality or rehospitalization for congestive heart failure(12 months)
- Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention(12 months)
- Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention(12 months)
- New York Heart Association (NYHA) stage III or IV(12 months)
Investigators
Sebastian Ludwig
Sebastian Ludwig, M.D., Principal Investigator
Universitätsklinikum Hamburg-Eppendorf