Abbott has announced that the US Food and Drug Administration (FDA) has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s MitraClip device 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 from the current indication of patients at prohibitive risk for surgery to also include patients at moderate risk.
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 MR who are candidates for open-heart surgery, which is the current standard of care today. The company statement says that 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 forego surgery due to prolonged recovery time or fear of possible surgical complications.1 2
Patrick McCarthy (Northwestern Medicine Bluhm Cardiovascular Institute, Chicago, USA), co-principal investigator of the REPAIR MR trial says in the statement: “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 aren’t 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 (Los Robles Hospital and Medical Center, Thousand Oaks, California, USA).
Mitral regurgitation (MR) is a debilitating, progressive and life-threatening disease in which the heart’s mitral valve does not close completely, causing blood to flow backward and leak into the atrium of the heart. The condition is the most common valve disease worldwide and can lead to reduced quality of life, recurrent hospitalisations and decreased survival.
Abbott’s MitraClip system has been commercially available in the USA since 2013 and in Europe since 2008 and, says Abbott’s press release, has shown significant impact for patients with both primary and secondary MR who are at high risk for open-heart surgery. The MitraClip therapy—now on a fourth generation of innovation—has shown improved clinical outcomes and quality of life through a minimally invasive option that reduces MR’s debilitating symptoms.
Neil Moat, chief medical officer of Abbott’s structural heart business, says in the the statement: “Abbott is leading the way in the structural heart space. We’re 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.”