The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, 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, randomised REPAIR MR clinical trial will enrol approximately 500 patients at 60 sites in the USA, Canada and Europe to evaluate the effectiveness of the MitraClip device in moderate-surgical-risk patients with severe primary mitral regurgitation who are candidates for open-heart surgery. The trial’s design seeks to address the issue that—despite symptoms and increased mortality for people with mitral regurgitation—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 mitral regurgitation receive surgical treatment. In some cases, this may be because the mitral regurgitation goes undiagnosed, but in others, patients may forgo surgery due to prolonged recovery time or fear of possible surgical complications.
Patrick McCarthy (Northwestern Medicine, Chicago, USA), co-principal investigator of the REPAIR MR trial, comments: “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. This is an important question since approximately 70% of people diagnosed with primary mitral regurgitation are not treated with open-heart mitral valve surgery today yet are in need of treatment and symptom relief.”
The trial will also be led by co-principal investigator Saibal Kar, director of structural heart disease and research, Los Robles Hospital and Medical Center (Thousand Oaks, USA).
Neil Moat, chief medical officer of Abbott’s structural heart business, states: “Abbott is leading the way in the structural heart space. We are pushing the field forward by making clinical investments to examine whether new, minimally invasive treatment options are suitable, or even preferable, to what has been the standard of care. Devices that can be delivered through a minimally invasive method to close or repair a significant structural issue in the heart are in high demand, and we are committed to continuing our efforts to bring the benefits of these devices to patients who need them.”