Mitral Regurgitation Clinical Trial
— MVRepairOfficial title:
MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | November 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: - All patients with recurrent mitral regurgitation treated with a MitraClip®. Exclusion Criteria: - Patient with endocarditis, - Patients with torn mitral valve ring. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Germany | Munich University Hospital | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Klinikum der Universitaet Muenchen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | 1 year | No | |
Primary | MR (mitral regurgitation) grade after clip treatment | Scale 0-4 | 1 year | No |
Secondary | MR (mitral regurgitation) grade at latest follow up | Scale 0-4 | 1 year | No |
Secondary | NYHA status at latest follow up | 1 year | No | |
Secondary | Distance in 6 minute walk test at latest follow up | 1 year | No | |
Secondary | LVEF (left ventricular ejection fraction) at latest follow up | 1 year | No | |
Secondary | LVEDV (left ventricular enddiastolic volume) at latest follow up | 1 year | No | |
Secondary | LVEDD (lef ventricular enddiastolic diameter) at latest follow up | 1 year | No | |
Secondary | Mean mitral valve gradient | 1 year | No | |
Secondary | Procedural complications | index procedure | No | |
Secondary | Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve | combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation) | 1 year | No |
Secondary | Clip success based on type of sMVR | success defined as reduction of 1 MR grade (scale 0-4) | index procedure | No |
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