PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair

Study Overview
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Brief Summary
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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
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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)

Official Title
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PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair: A Prospective, Single-center, Open-label Study

Conditions
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Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation

Intervention / Treatment
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* Device: PASCAL vs. MitraClip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PASCAL-Group<br>M-TEER using MitraClip | Device: PASCAL vs. MitraClip<br>* 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.<br>|
| MitraClip-Group<br>M-TEER using PASCAL | Device: PASCAL vs. MitraClip<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | as defined by the Mitral Valve Academy Research Consortium (MVARC) | one month after implantation | 
| Composite endpoint of all-cause death and heart failure hospitalization |  | one year after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of Mitral Regurgitation | measured by echocardiography | one month and one year after implantation | 
| Functional status | according to New York Heart Association (NYHA) functional class | one month and one year after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Regurgitation, Functional Mitral Regurgitation, Degenerative Mitral Valve Regurgitation, M-TEER, TEER