Feature | October 15, 2010

CoreValve Transcatheter Valve Trial Receives FDA Approval

October 15, 2010 – An investigational trial of Medtronic’s CoreValve transcatheter aortic valve has been approved by the U.S. Food and Drug Administration (FDA) today. The investigational device exemption (IDE) pivotal clinical trial will enroll more than 1,200 patients at 40 U.S. clinical sites.

The CoreValve system is designed to provide a minimally invasive, nonsurgical treatment option for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery. Worldwide, approximately 300,000 people have been diagnosed with this condition. About one-third of these patients are deemed at too high a risk for open-heart surgery, the only therapy with significant clinical effect that is currently available in the United States. The CoreValve System will soon be under investigational use and is not yet commercially available in the United States.

The studies will evaluate the safety and efficacy of CoreValve in two groups of patients with severe aortic stenosis: those who have been deemed high risk for aortic valve surgery, and those who have been deemed at extreme risk for aortic valve surgery (i.e. inoperable).

“There is a distinct need for a new treatment option for many older patients with a severely diseased aortic heart valve and, as the population ages, this need continues to grow,” said Jeffrey Popma, M.D., Medtronic CoreValve U.S. pivotal trial co-principal investigator based at Beth Israel Deaconess Medical Center in Boston.

The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously, usually through the femoral artery, without open-heart surgery or surgical removal of the native valve. Since receiving CE (Conformité Européenne) mark in March 2007, the system has been implanted in more than 12,000 patients worldwide in more than 34 countries outside the United States.

“This study represents a significant opportunity to fundamentally change the way we treat Americans with severe aortic stenosis,” said David H. Adams, M.D., professor and chairman of the department of cardiothoracic surgery at The Mount Sinai Medical Center in New York City and co-principal investigator of the CoreValve trial. “Cardiologists and cardiac surgeons will collaborate more closely than ever before to carefully select and deliver this innovative therapy.”

Symptomatic Severe Aortic Valve Stenosis
Aortic stenosis is a condition of the aortic valve which prevents the valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.

Study Details
The studies will evaluate the treatment’s safety and efficacy in two groups of patients with severe aortic stenosis: those who have been diagnosed as high risk for aortic valve surgery, and those who have been deemed at extreme risk for aortic valve surgery (i.e. inoperable).

Patients who are considered at high surgical risk will be randomized one-to-one to either transcatheter aortic valve implantation (TAVI) with CoreValve or to surgical aortic valve replacement (SAVR). The primary endpoint for this trial is freedom from all-cause mortality at 12 months.

Study participants deemed at extreme risk for surgical valve replacement will be randomized two-to-one to receive either TAVI with CoreValve or optimal medical management. This trial has co-primary endpoints: all-cause death or major stroke occurring within a minimum of 12 months of follow-up; and a composite of all-cause death, major stroke, days of hospitalization for aortic valve disease, and number of hospitalizations for aortic valve disease occurring within a minimum of 12 months of follow-up.

For more information: www.clinicaltrials.gov, www.medtronic.com

Related Content

DEFUSE-2 study, MRI, brain bleeding risk, post-stroke treatment, NIH

This image combines pre- and post-treatment scans from the same patient. Analysis of the two scans revealed that the area and size of post-treatment bleeding corresponded to blood-brain barrier disruption (shown in green, yellow and red) prior to therapy. Image courtesy of Richard Leigh, NINDS.

News | Stroke| June 29, 2016
In a study of stroke patients, investigators confirmed through magnetic resonance imaging (MRI) brain scans an...
Sponsored Content | Videos | Cardiovascular Ultrasound| June 28, 2016
Interview with Rebecca Hahn, M.D., FASE, Columbia University Medical Center, New York, at the American Society of Ech
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study| June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
CT scans, cancer risk, radiation dose, Canadian study
News | Computed Tomography (CT)| June 27, 2016
June 27, 2016 — A new study in the Journal of Medical Imaging and Radiation Sciences surveyed doctors, radiologists a
News | Cardiac Diagnostics| June 24, 2016
Measuring antibody levels in the blood could be used to detect a person’s heart attack risk after researchers, part-...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
News | Implantable Cardioverter Defibrillators (ICD)| June 14, 2016
Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter...
hypertrophic cardiomyopathy, HCM, strain echocardiography, risk assessment, ASE 2016
News | Cardiovascular Ultrasound| June 13, 2016
After following a large sub-set of patients, researchers found that by using strain echocardiography they could...
ASE 2016, Mayo Clinic study, echocardiography, aortic flow rate, patient risk stratification
News | Cardiovascular Ultrasound| June 13, 2016
Researchers from Mayo Clinic believe they have found a better way to risk stratify some of their most fragile patients.
Overlay Init