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Active Not Recruiting
NCT04430075
MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Conditions: Mitral Regurgitation, Mitral Insufficiency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Edwards Lifesciences
Location: Medizinische Universität Wien/AKH Wien Vienna
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 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 not eligible per the current Instructions for Use
2. Non-elective or emergency TEER procedure for mitral regurgitation
3. Patients in ICU prior to the index procedure
Source: ClinicalTrials.gov (NCT04430075). StuddyBuddy aggregates publicly available trial information.
