Mitral Regurgitation
Conditions
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.
Interventions
DEVICEPercutaneous edge-to-edge repair of the mitral valve
MitraClip in patients with recurrent MI after surgical mitral valve repair.
Sponsors
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* All patients with recurrent mitral regurgitation treated with a MitraClip®.
Exclusion criteria
* Patient with endocarditis, * Patients with torn mitral valve ring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1 year | — |
| MR (mitral regurgitation) grade after clip treatment | 1 year | Scale 0-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance in 6 minute walk test 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 | — |
| MR (mitral regurgitation) grade at latest follow up | 1 year | Scale 0-4 |
| Procedural complications | index procedure | — |
| Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve | 1 year | combined endpoint defined as freedom from each Event (death, MR grade \>2 or reintervention/Operation) |
| Clip success based on type of sMVR | index procedure | success defined as reduction of 1 MR grade (scale 0-4) |
| Mean mitral valve gradient | 1 year | — |
| NYHA status at latest follow up | 1 year | — |
Countries
Germany
Contacts
Primary ContactDaniel Braun, MD
Backup ContactJörg Hausleiter, MD
Outcome results
None listed