A new catheter-based treatment for mitral valve regurgitation is currently under investigation via the COAPT Trial (Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients Trial). The trial is evaluating the safety and effectiveness of the MitraClip device in patients who have been diagnosed with moderate-to-severe or severe functional mitral regurgitation-the valve is structurally normal but leaks because of changes to the size and/or shape of the heart-and who are too high risk to undergo mitral valve surgery.
The MitraClip device is a mechanical clip which is advanced on a catheter delivery system, most often through the femoral vein in the groin, and guided by a special type of x-ray and ultrasound to the mitral valve. The device grasps and coapts the leaflets together reducing the opportunity for blood to flow back into the left atrium.
Process to Enroll
You will need to be screened by our team of physicians and physician assistants to determine whether you meet the medical criteria to enroll in the trial. The screening process can take up to a few days.
On the first day, one of our physician assistants will ask you a series of questions and will do a medical examination to determine your level of risk for a surgical procedure. To participate in the COAPT Trial you must be high-risk for surgery as determined by the heart team. You will also have an echocardiogram to confirm that you have moderate-to-severe or severe functional mitral regurgitation.
If the echocardiogram reveals that you fit the criteria, you will return for a second day of evaluation. On day two, you will have a transesophageal echocardiogram (TEE). The TEE will provide a closer look at the mitral valve, unobstructed by ribs or lungs, helping us to determine whether your valve’s anatomy is appropriate for the MitraClip device. You will also meet with a heart failure specialist who will evaluate your medications. Patients must be on "optimal medical therapy" for at least 30 days and still experiencing symptoms of the disease to qualify for the trial. The heart failure specialist may adjust your medication for up to 30 days before he/she can determine whether you are a candidate for the trial. The COAPT Trial is a randomized study, which means patients will be arbitrarily assigned to either the MitraClip device or ongoing medical management of the disease. Our physicians do not determine or influence which therapy you receive.
Patients enrolled in the COAPT Trial are required to sign a consent form. You will meet with a clinical research coordinator or a physician assistant to discuss the consent form in detail. You will have the opportunity to take the consent form with you to review with your family and friends. You will also be provided with the name and contact number of an experienced member of our team to address any questions. If you agree to participate in the trial, you must sign the consent form. Participation in a clinical trial is always voluntary and you are able to withdraw from participating.
For further information contact Kate Dalton at 212-342-0444.