The FDA has given Edwards Lifesciences approval for an expanded indication study of its Sapien 3 valve. The investigational device exemption (IDE) study will enrol elderly patients with severe, symptomatic aortic stenosis who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.
Patients enrolled in the new PARTNER III trial will be randomised to receive either the Sapien 3 valve or open surgical valve replacement. To be eligible for the trial, patients must be at least 65 years old, exhibit symptoms of severe aortic stenosis and be determined by a heart team to have a surgical risk score of less than 4% per the Society of Thoracic Surgeons adult cardiac surgery risk calculator. The trial is a non-inferiority study with a one-year composite endpoint that includes death, stroke and rehospitalisation. Enrolment of approximately 1,300 patients at up to 50 sites is expected to begin during the second quarter. The trial will also include a 400-patient substudy using advanced imaging to evaluate leaflet motion in tissue heart valves.
Larry Woods, Edwards’ corporate vice president, transcatheter heart valves, says: “If this trial is successful, it will allow heart teams to choose a treatment approach that is best suited to every patient’s individual need. We are pleased to begin this important study of the Sapien 3 transcatheter valve to evaluate its safety and effectiveness in a broader group of elderly patients suffering from this deadly disease.”