News | March 21, 2007

Edwards to Begin Transcatheter Heart Valve Trial

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.

Related Content

Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System
Feature | Heart Valve Technology | April 23, 2019 | Dave Fornell, Editor
Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) approval for the Lotus Edge...
New Consensus Document Explores Optimized Care for Valvular Heart Disease Patients
News | Heart Valve Technology | April 22, 2019
April 22, 2019 — Five cardiovascular professional societies released a new consensus document on optimizing care for
Mick Jagger Recovering After TAVR Procedure
News | Heart Valve Technology | April 08, 2019 | Jeff Zagoudis, Associate Editor
Rolling Stones frontman Mick Jagger is reportedly recovering after undergoing a transcatheter aortic valve valve...
 Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs. 6.7 percent; posterior probability of non-inferiority >0.999), was presented at the American College of Cardiology (ACC) 2019 meeting
News | Heart Valve Technology | April 03, 2019
April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transc
TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients
News | Heart Valve Technology | March 22, 2019
Among patients with severe symptomatic aortic stenosis at low surgical risk, transcatheter aortic valve replacement (...
ACC Launches Transcatheter Valve Certification
News | Heart Valve Technology | March 14, 2019
March 14, 2019 — Beginning in mid-2019, hospitals performing...
FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation
Feature | Heart Valve Technology | March 14, 2019 | Jeff Zagoudis, Associate Editor
March 14, 2019 — The U.S.
Overlay Init