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Clinical trial

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

NCT04097145 is registered in ClinicalTrials.gov with Edwards Lifesciences as lead sponsor.

NCT NCT04097145
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Registry record

As filed in ClinicalTrials.gov.

Title
A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
Lead sponsor
Edwards Lifesciences
Phase
Not applicable
Overall status
Recruiting
Start date
December 11, 2019
Completion date
December 31, 2031
Enrollment
1,270 (estimated)
Sites
79

Conditions

As the registry lists them; a condition with its own page is linked.

tricuspid regurgitation, tricuspid valve disease, tricuspid valve insufficiency