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MiCLASP Post Market Clinical Follow-Up (PMCF) Study

RECRUITINGSponsored by Edwards Lifesciences
Actively Recruiting
SponsorEdwards Lifesciences
Started2019-08-23
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04430075

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Heart DiseaseMitral InsufficiencyMitral Regurgitation

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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