Degenerative Mitral Valve Regurgitation, Functional Mitral Regurgitation, Mitral Regurgitation
Conditions
Keywords
Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation, M-TEER, TEER
Brief summary
Comparsion of the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety in patients with degenerative mitral regurgitation (DMR) and in patients with functional regurgitation (FMR), who were referred for an interventional therapy by the heart team due to a high surgical risk profile.
Detailed description
A prospective single-center, open-label study to evaluate the safety and effectiveness of transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System compared to using the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device. Treating physicians had no influence on scheduling or system selection. Follow-up examinations will be performed one month and one year after the procedure with assessment of echocardiographic and functional status based on the New York Heart Association (NYHA) grade. Patient characteristics, baseline data, and data related to the procedure were assessed using a registry, medical records and the procedure protocols. This study is a subproject of the MitraClip® Registry (NCT02033811)
Interventions
DEVICEPASCAL vs. MitraClip
transcatheter mitral valve repair of the mitral valve (M-TEER) using the Edwards PASCAL Transcatheter Valve Repair System or the Abbott MitraClip in patients with severe and symptomatic degenerative or functional mitral regurgitation (FMR). The type of device system used was not randomized but was determined by the operational structuring of the mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip device and PASCAL device.
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Severe Mitral Regurgitation (3+ to 4+) * Symptom status: NYHA functional class ≥ II * Patients with FMR or DMR, who were referred for M-TEER by the heart team decision due to a high
Exclusion criteria
* Life expectancy \< 1 year * Anatomy of the mitral valve that may not be suitable for the MitraClip or PASCAL device * Contraindication for transoesophageal echocardiography * Active endocarditis * Pregnant or planning pregnancy within next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | one month after implantation | as defined by the Mitral Valve Academy Research Consortium (MVARC) |
| Composite endpoint of all-cause death and heart failure hospitalization | one year after implantation | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of Mitral Regurgitation | one month and one year after implantation | measured by echocardiography |
| Functional status | one month and one year after implantation | according to New York Heart Association (NYHA) functional class |
Countries
Germany
Outcome results
None listed