Edwards CLASP TR EFS
Completed · Not applicable
Conditions studied: Tricuspid Regurgitation
In brief
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Key facts
- Study ID
- NCT03745313
- Run by
- Edwards Lifesciences
- People needed
- 65
- Starts
- 2019-02-05
- Expected to finish
- 2025-05-13
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- NYU Langone Health — New York, New York, United States
- Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Lankenau Medical Center — Wynnewood, Pennsylvania, United States
- The Heart Hospital Baylor Plano — Plano, Texas, United States
- Intermountain Medical Center — Murray, Utah, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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