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 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 treat tricuspid regurgitation.
This interventional study is randomized with a parallel assignment model and no masking. Its primary purpose is treatment, comparing the Edwards PASCAL System plus OMT against OMT alone.
The study began on December 11, 2019, with primary completion and estimated completion dates yet to be updated. The latest update was submitted on June 30, 2025, indicating ongoing recruitment.
The outcome of this study could significantly impact Edwards Lifesciences’ stock performance, as positive results may enhance investor confidence and market position, especially in comparison to competitors in the cardiac device industry.
The study is ongoing, with further details available on the ClinicalTrials portal.