Abbott to initiate REPAIR MR trial of MitraClip for people with primary mitral regurgitation eligible for open-heart surgery.

Abbott announced that the FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott's minimally invasive MitraClip device – which has now treated 100,000 patients worldwide – to open heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. If successful, the trial has the potential to expand treatment options for patients who are suffering from leaking mitral valves and whose current options are limited to open-heart surgery. The prospective, randomized REPAIR MR clinical trial will enroll approximately 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 today. The trial's design addresses the issue that, despite symptoms and increased mortality for people suffering from MR, patients are often undertreated by open-heart mitral valve surgery. Currently, only an estimated 15% 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.