Global SURTAVI Trial Begins for Medtronic's CoreValve System in Intermediate-Risk Patients

July 18, 2012—Medtronic, Inc. (Minneapolis, MN) announced the commencement of enrollment in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) clinical trial comparing its transcatheter CoreValve system with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk for open heart surgery. The global multicenter randomized trial will evaluate the CoreValve system for patients who are typically are treated with open heart surgical aortic valve replacement.

According to Medtronic, the trial will nominally evaluate approximately 2,500 patients at up to 75 clinical sites with experienced heart teams that include interventional cardiologists and cardiac surgeons. Investigators will evaluate whether the CoreValve system is noninferior to surgical valve replacement based on the composite primary endpoint of all-cause mortality and major stroke at 24 months. Medtronic advised that it is working with the US Food and Drug Administration to include patients from the United States in the trial.

As summarized in the company's announcement, patients considered for the trial include those with severe, symptomatic aortic stenosis who are classified as intermediate surgical risk, as defined by a Society of Thoracic Surgeons mortality risk of ≥ 4% and ≤ 10%. Patients will be randomized on a 1:1 basis to either transcatheter aortic valve replacement with CoreValve or to surgery. CoreValve implantation can be performed via transfemoral, subclavian, or direct aortic access, depending on the needs of the patient. All patients will be followed through 5 years.

The Chairman of the SURTAVI trial is Patrick Serruys, MD, Professor of Medicine and Head of the Department of Interventional Cardiology at Erasmus Medical Center in Rotterdam, The Netherlands. The trial's Principal Investigator is A. Pieter Kappetein, MD, Professor of Cardiothoracic Surgery at Erasmus Medical Center. Interventional cardiologist Lars Sondergaard, MD, and cardiothoracic surgeon Daniel Steinbruchel, MD, performed the first procedures at Rigshospitalet Copenhagen University Hospital in Copenhagen, Denmark.

In Medtronic's press release, Professor Serruys commented, “Transcatheter aortic valve replacement is a transformational, potentially lifesaving technology that typically is used to treat inoperable patients or patients for whom surgery carries high risks. The SURTAVI trial will offer guidance on how to best treat intermediate-risk patients and may substantiate the CoreValve system as an attractive alternative treatment for these patients.”

Prof. Kappetein added, “We are pleased to begin this important trial that may demonstrate the benefits of the CoreValve system in a broader population of patients with severe aortic stenosis. This study represents a significant opportunity to bring a new therapy to physicians and a large percentage of patients, both of whom are looking for a less-invasive option to treat aortic stenosis.”

The company noted that the CoreValve system received CE Mark approval in 2007 and is approved for implantation via the direct aortic approach and the subclavian approach. It is available in three sizes (26, 29, and 31 mm). In the United States, the device is currently limited to investigational use only.