Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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The PROGRESS Trial, officially titled ‘The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement,’ aims to evaluate the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in patients with moderate, calcific aortic stenosis. This study is significant as it could redefine treatment protocols for this condition.
The intervention being tested is the Transcatheter Aortic Valve Replacement (TAVR) using the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA devices. These devices are designed to replace the aortic valve in patients, aiming to improve heart function and patient outcomes.
This is an interventional study with a randomized, parallel assignment model. There is no masking involved, and the primary purpose is treatment. Participants are either assigned to receive TAVR or undergo clinical surveillance.
The study began on October 12, 2021, and is currently recruiting. The last update was submitted on July 8, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
The update on this study could influence Edwards Lifesciences Corp.’s stock performance positively, as successful results may enhance investor confidence and market position. Competitors in the heart valve market may also feel the pressure to innovate or improve their offerings.
The PROGRESS Trial is ongoing, with further details available on the ClinicalTrials portal.