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Completed
NCT03745313
Edwards CLASP TR EFS
Conditions: Tricuspid Regurgitation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 65
Sponsor: Edwards Lifesciences
Location: Cedars Sinai Medical Center Los Angeles California
Summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03745313). StuddyBuddy aggregates publicly available trial information.
