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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): 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
Description
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
Details
Age
Adult
Phase
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Type of Study
Treatment
Locations
Harmony Campus
Medical Center of the Rockies
Principal Investigator
Mohamad Lazkani
Study ID
Protocol Number: 19-6129
ClinicalTrials.gov: NCT04097145
Categories
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