CompletedNot Applicable

Edwards CLASP TR EFS

United States65 participantsStarted 2019-02-05

Plain-language summary

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Severe functional or degenerative TR * Symptomatic despite medical therapy * The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair Exclusion Criteria: * Unsuitable anatomy * Previous tricuspid valve repair or replacement * Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

What they're measuring

Composite Major Adverse Event (MAE) Rate

Timeframe: 30 days

Trial details

NCT IDNCT03745313

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-11

Results submitted2024-05-10

View on ClinicalTrials.gov More Tricuspid Regurgitation trials