March 16, 2010 — Several new initiatives in a robust international clinical program for a transcatheter aortic valve system have been set in motion with the goal of expanding the evidence base for the future of structural heart disease therapy.
Medtronic Inc. launched the study for its CoreValve transcatheter aortic valve system, a minimally invasive alternative to open-heart surgery for aortic valve replacement.
The CoreValve Advance clinical study began enrolling patients last week, with the first two implants occurring in Germany. CoreValve Advance is a prospective, observational international post-market study to evaluate clinical outcomes of patients with severe aortic stenosis who are treated with the CoreValve system in standard clinical practice. The CoreValve system received CE mark in March 2007. It is not yet available in the United States for commercial sale or clinical use.
“The CoreValve Advance study is Medtronic’s first major clinical evaluation of the CoreValve system since we acquired it in April 2009,” said John Liddicoat, M.D., cardiac surgeon, vice president and general manager of the structural heart division, part of the CardioVascular business, at Medtronic. “It is one of several CoreValve studies planned to begin this year worldwide as part of a rigorous, long-term clinical program.”
Approximately 1,000 patients with severe aortic stenosis will be enrolled in CoreValve Advance at up to 90 clinical trial sites in countries where the CoreValve system is commercially available. Most of the trial sites will be in Europe, where the CoreValve system is used in approximately 75 percent of transcatheter aortic valve replacements involving percutaneous femoral access.
The principal and co-principal investigators of CoreValve Advance are professor Axel Linke, Universität Leipzig Herzzentrum, and professor Robert Bauernschmitt, Deutches Herzzentrum München, both in Germany. The first study procedures were performed by professor Horst Sievert, CardioVascular Center Frankfurt, also in Germany.
“We have been very pleased with past clinical results using the CoreValve system, and we anticipate great scientific value for future patients by participating in the CoreValve Advance study,” said professor Sievert. “The resulting data will provide important information to physicians and regulatory officials worldwide related to broad-scale safety and device performance for patients with severe aortic stenosis who often are at high risk for open-heart surgery.”
Study patients will be followed for at least five years following implantation of CoreValve. The primary endpoint is major adverse cardiac and cerebrovascular events (MACCE) at 30 days following the procedure, with MACCE defined as a composite of: all-cause mortality; myocardial infarction; emergent cardiac surgery or percutaneous reintervention; and stroke. The study also includes 19 secondary endpoints and data collection related to the health economic impact of CoreValve on patient quality of life and therapy cost-effectiveness.
The CoreValve system is designed to enable replacement of a diseased aortic valve without open-heart surgery or surgical removal of the native valve. Typically delivered through the femoral artery, it has been implanted in more than 7,500 patients worldwide and is now available in 29 countries outside the United States.
For more information: www.medtronic.com