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Study identifier: NCT04097145 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Condition: Tricuspid Regurgitation · Tricuspid Valve Insufficiency · Tricuspid Valve Disease  ·  Sponsor: Edwards Lifesciences

PhaseNA
Planned participants1270
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

This description comes directly from the study's public registry record.

Talk to the study team

Edwards TMTT Clinical Affairs  ·  (949) 250-2500  ·  TMTT_Clinical@edwards.com

Always discuss trial participation with your own doctor first.

Locations (79)

Banner University Medical Center PhoenixPhoenix, Arizona, United StatesActive Not Recruiting
Tucson Medical Center HealthcareTucson, Arizona, United StatesActive Not Recruiting
University of California, IrvineIrvine, California, United StatesRecruiting
SCPMG - Kaiser San DiegoLa Jolla, California, United StatesActive Not Recruiting
Cedars Sinai Medical CenterLos Angeles, California, United StatesActive Not Recruiting
UCLA Medical CenterLos Angeles, California, United StatesActive Not Recruiting
Kaiser Permanente San FranciscoSan Francisco, California, United StatesActive Not Recruiting
University of California, San FranciscoSan Francisco, California, United StatesRecruiting
Stanford UniversityStanford, California, United StatesActive Not Recruiting
St. Joseph HospitalDenver, Colorado, United StatesRecruiting
Medical Center of the RockiesLoveland, Colorado, United StatesActive Not Recruiting
The Cardiac and Vascular Institute Research FoundationGainesville, Florida, United StatesRecruiting

+ 67 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04097145