March 22, 2007 — Edwards Lifesciences Corp. says it has received conditional FDA approval to initiate a pivotal clinical trial of the SAPIEN transcatheter aortic heart valve technology. The PARTNER (Placement of AoRTic traNscathetER valves) trial will evaluate the SAPIEN valve in patients who are considered high risk for conventional open-heart valve surgery.
The prospective randomized clinical trial includes two separate treatment arms. The surgical arm of the trial will focus on approximately 350 high-risk patients who are candidates for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or surgical valve replacement. The clinical results of this arm will need to demonstrate that the SAPIEN valve is not statistically inferior to conventional surgery.
The medical management arm of the trial will focus on approximately 250 patients that are considered too high risk for conventional open-heart surgery. Those patients will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or appropriate medical therapy. The clinical results of this arm will need to demonstrate that the SAPIEN valve is statistically superior to medical management.
The primary endpoint in both arms of the trial is mortality at one year with secondary endpoints that focus on valve performance and quality-of-life indicators. Each arm of the trial contains a sufficient number of patients to support independent statistical analysis.
Edwards will start enrolling at two initial study sites: New York-Presbyterian/Columbia University Medical Center, New York, and The Cleveland Clinic Foundation, Cleveland, Ohio. Both were part of the company's earlier transfemoral feasibility study. Before expanding to 15 U.S. study sites, Edwards needs to submit additional follow-up data from the original 55-patient feasibility study.