Edwards Lifesciences Corp. ((EW)) announced an update on their ongoing clinical study.
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Edwards Lifesciences Corp. is conducting the ALT-FLOW II Trial, officially titled ‘A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System.’ The study aims to evaluate the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system in treating patients with heart failure with preserved or mildly reduced ejection fraction who remain symptomatic despite standard medical therapy.
The intervention being tested is the Edwards APTURE transcatheter shunt system, a device designed to assist patients with heart failure by improving heart function and symptoms.
This is a prospective, multi-center, randomized, sham-controlled, double-blinded trial. Participants are randomly assigned to receive either the APTURE shunt system or a sham procedure, with both participants and outcomes assessors blinded to the assignment. The primary purpose of the study is treatment.
The study began on April 1, 2023, with an estimated primary completion date not yet disclosed. The latest update was submitted on August 4, 2025, indicating ongoing recruitment and progress.
This clinical trial update could influence Edwards Lifesciences’ stock performance by potentially enhancing investor confidence if the results prove favorable. The trial’s outcome may also affect competitive dynamics in the heart failure treatment market.
The ALT-FLOW II Trial is ongoing, with further details available on the ClinicalTrials portal.