Clinical Trial Update: REPAIR MR Now Enrolling Patients to Evaluate MitraClip in Moderate Risk Patients

Big, big, big news!

Over the years, we have seen the MitraClip™ therapy have a profound impact on patients with severe mitral regurgitation. From Michelle Golden to David Lugo to Charlotte Cummings, the MitraClip™ therapy has successfully treated patients who were short of breath, constantly fatigued, and on heart transplant lists.

While the MitraClip™ therapy has already received FDA approval for patients who are at prohibitive or high surgical risk, a new clinical trial will evaluate the use of the less invasive MitraClip™ implant in patients who are candidates for mitral valve surgery but are at moderate surgical risk. This new research study is known as the REPAIR MR Clinical Trial.

What is the REPAIR MR Clinical Trial?

The primary objective of the REPAIR MR Clinical Trial is to compare clinical outcomes of transcatheter treatment using the MitraClip™ implant to surgical repair in patients with mitral regurgitation. The MitraClip™ therapy (Abbott, Santa Clara, CA, USA) uses a less invasive procedure to repair the mitral valve. The MitraClip™ therapy does not require an incision to the patient’s chest or ribs and the patient is not required to go on the heart-lung machine.

The MitraClip™ system, now on its fourth-generation device, has been commercially available in the United States since 2013 and in Europe since 2008. There have been over 100,000 implants worldwide.

Why is the REPAIR MR Clinical Trial Such a Big Deal for Patients?

The REPAIR MR research study seeks to evaluate the MitraClip™ in treating a new patient population that currently undergoes standard surgical treatment but may be at a higher risk for prolonged hospitalization or morbidity with mitral valve surgery, such as elderly patients who may be looking for a less invasive treatment option for their mitral valve disease.

Dr. Patrick McCarthy

As Dr. Patrick McCarthy, the national co-principal investigator of the REPAIR MR Clinical Trial and Chief of Cardiac Surgery at Northwestern Medicine, shared with me, “This is important research since approximately 70% of people diagnosed with primary mitral regurgitation are not treated with mitral valve surgery today – yet, are in need of treatment and symptom relief.” (Yes, you read that right. 70% of patients do not get treatment.)

What Impact Might the REPAIR MR Clinical Trial Have on the Future of Mitral Valve Surgery?

This research study will compare the clinical outcomes of the MitraClip™ implant to mitral valve surgical repair.

Dr. Saibal Kar

Dr. Saibal Kar, the national co-principal investigator of the REPAIR MR Clinical Trial and interventional cardiologist at Los Robles Healthcare, shared with me, “If successful, this research study has the potential to expand treatment options for patients with mitral valve disease, whose current options are limited to open heart surgery.”

Dr. Kar & Me (Adam)

Fyi, I was fortunate to see Dr. Kar implant a MitraClip™ several years ago.

Who Can Enroll in the REPAIR MR Clinical Trial?

The REPAIR MR Clinical Trial will enroll approximately 500 patients at 60 sites in the United States, Canada and Europe to evaluate the effectiveness of the MitraClip™ device in patients at moderate surgical risk with severe mitral regurgitation who are candidates for heart surgery. The trial is currently enrolling.

Next: Click here to learn more about the REPAIR MR Clinical Trial.

Keep on tickin!
Adam