RecruitingNCT04430075
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
Sponsor
Edwards Lifesciences
Enrollment
1,000 participants
Start Date
Aug 23, 2019
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
- Patient is willing and able to attend all follow-up visits and to perform all tests
- Provision of written informed consent
Exclusion Criteria3
- Patients are not eligible per the current Instructions for Use
- Non-elective or emergency TEER procedure for mitral regurgitation
- Patients in ICU prior to the index procedure
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Interventions
DEVICEEdwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Locations(37)
View Full Details on ClinicalTrials.gov
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NCT04430075
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