The U.S. Food and Drug Administration (FDA) has approved #clinical trial that will compare the effectiveness of Abbott's minimally invasive Mitral transcatheter mitral valve repair device to open heart mitral valve #surgical repair in moderate risk surgical patients. If successful, the trial may expand treatment options for patients who are suffering from primary mitral regurgitation (MR) whose current options are limited to open-heart surgery.
The #MitraClip's current FDA indication is for high-risk surgical patients who have a leaking mitral valve. The device has been implanted in more than 100,000 patients worldwide. It is currently the only FDA cleared #transcatheter mitral valve repair device.
- The prospective, randomized #REPAIR MR clinical trial will enroll about 500 patients at 60 sites in the U.S., Canada and Europe to evaluate the effectiveness of the MitraClip device in moderate surgical risk patients with severe primary MR who are candidates for open-heart #surgery, which is the current standard of care. The trial's design addresses the issue that, despite symptoms and increased mortality for people suffering from MR, patients are often under treated by open-heart mitral valve surgery. Currently, only an estimated 15 percent of patients who are eligible for the standard-of-care surgery for their primary MR receive surgical treatment. In some cases, this may be because the MR goes undiagnosed, but in others, patients may forgo surgery due to prolonged recovery time or fear of possible surgical complications.
- "The REPAIR MR trial seeks to evaluate the MitraClip device in treating a new patient population who currently undergo the standard surgical treatment, but are at moderate surgical risk," said Patrick McCarthy, M.D., chief of cardiac surgery, Northwestern Medicine, executive director, Bluhm Cardiovascular Institute and co-principal investigator of the REPAIR MR trial. "This is an important question since approximately 70 percent of people diagnosed with primary mitral regurgitation aren't treated with open-heart mitral valve surgery today, yet are in need of treatment and symptom relief."