Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting a pivotal clinical trial titled 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. The study aims to assess the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with severe tricuspid regurgitation who are at an intermediate or higher risk of mortality from traditional surgery.
The intervention being tested is the Edwards PASCAL Transcatheter Valve Repair System, a device designed for transcatheter tricuspid valve repair, used alongside optimal medical therapy (OMT) to improve patient outcomes.
This interventional study is randomized with a parallel intervention model and no masking, focusing primarily on treatment. Participants are allocated to either the Edwards PASCAL System with OMT or OMT alone, with follow-ups scheduled at various intervals up to five years.
The study began on December 11, 2019, and is currently recruiting participants. The primary completion date is yet to be determined, with the last update submitted on July 7, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
The outcome of this study could significantly impact Edwards Lifesciences’ stock performance and investor sentiment, as positive results may enhance the company’s market position in the cardiovascular device industry. Competitors in the transcatheter valve repair market will be closely monitoring these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.