MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Recruiting
Observational Study
Mitral Regurgitation
Mitral Insufficiency
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
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About This Trial
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
2. Patient is willing and able to attend all follow-up visits and to perform all tests
3. Provision of written informed consent
Exclusion Criteria:
1. Patients are no…
Contacts