MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- LMU Klinikum
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Survival
- Last Updated
- 9 years ago
Overview
Brief Summary
Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.
Detailed Description
In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.
Investigators
Daniel Braun, MD
MD
LMU Klinikum
Eligibility Criteria
Inclusion Criteria
- •All patients with recurrent mitral regurgitation treated with a MitraClip®.
Exclusion Criteria
- •Patient with endocarditis,
- •Patients with torn mitral valve ring.
Outcomes
Primary Outcomes
Survival
Time Frame: 1 year
MR (mitral regurgitation) grade after clip treatment
Time Frame: 1 year
Scale 0-4
Secondary Outcomes
- NYHA status at latest follow up(1 year)
- Distance in 6 minute walk test at latest follow up(1 year)
- MR (mitral regurgitation) grade at latest follow up(1 year)
- LVEF (left ventricular ejection fraction) at latest follow up(1 year)
- LVEDV (left ventricular enddiastolic volume) at latest follow up(1 year)
- LVEDD (lef ventricular enddiastolic diameter) at latest follow up(1 year)
- Mean mitral valve gradient(1 year)
- Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve(1 year)
- Procedural complications(index procedure)
- Clip success based on type of sMVR(index procedure)