Heart Valve Disease: COAPT Trial
Trial of MitraClip expands to more patients with mitral regurgitation.
The Heart Valve Center at NewYork-Presbyterian/Columbia is currently enrolling patients in the COAPT Trial,* which is evaluating a catheter-based (non-surgical) treatment for mitral valve regurgitation (often called a ‘leaky valve’).
Mitral valve regurgitation is a common disease in which the mitral valve, one of the heart’s four valves, fails to close properly due to changes in the valve tissue. As a result, blood leaks back into the upper chamber (left atrium) on the left side of the heart. This leakage impairs the normal flow of blood to the rest of the body, causing symptoms such as shortness of breath, irregular heartbeat, chest pain, and fatigue.
If a patient’s mitral valve disease is mild, symptoms may be controlled by medication, according to Tiffany Wong, PA, an expert in valve disease at the Heart Valve Center. If the disease is more severe, the valve may need to be surgically repaired or even replaced. Mitral valve repair and replacement can both extend life expectancy and improve patients’ quality of life by regulating the heartbeat and blood flow.
NYP/Columbia University Medical Center is regarded as a national leader in the development and use of minimally invasive approaches to treating heart valve disease. One well-known minimally invasive therapy, the MitraClip mitral valve repair system, has gained much traction since its development a decade ago by a team at NYP/Columbia (under the direction of Dr. Mehmet Oz at that time). Based on the results of the multicenter EVEREST and EVEREST II trials, MitraClip was approved in January 2014 for patients who have a form of mitral regurgitation called degenerative regurgitation and who are at high surgical risk. Now, MitraClip is the subject of a new trial among a broader population of patients — including those at high surgical risk whose mitral disease results from the typical aging process.
Tiffany Wong, PA answers commonly asked questions about MitraClip and the COAPT trial.
How does MitraClip treat mitral regurgitation?
A metal clip is advanced through the femoral vein in the groin and is guided to the heart with the aid of fluoroscopy (a special type of X-ray). Once it reaches the mitral valve with the aid of a transesophageal echocardiogram, the device then clips the leaflets of the mitral valve together to reduce the amount of blood that can flow back into the left side of the heart.
What are the advantages of MitraClip?
Some patients are not able to undergo surgery because they are too ill or frail to withstand an operation. The catheter-based alternative is far less traumatic, allowing for effective treatment without a chest incision, and sparing patients the pain and risks associated with surgery and post-operative recovery.
What are the risks associated with MitraClip?
While most people tolerate the procedure very well, there are risks including bleeding, infection, and vascular complications. The procedure requires the use of general anesthesia, which also carries risks.
What is the purpose of the COAPT trial?
The COAPT trial aims to evaluate the safety and effectiveness of the MitraClip system in patients who have moderate-to-severe functional mitral regurgitation and who are at too high risk to undergo mitral valve surgery. In this multicenter trial, patients will receive either medical therapy or MitraClip. The study will include 350 patients across North America, and patients will be followed for five years.
Who is eligible for inclusion in the COAPT trial?
Eligible patients include patients who have moderate-to-severe or severe functional mitral regurgitation (FMR), a form of mitral regurgitation in which the valve is structurally normal but leaks because of changes to the size and/or shape of the heart commonly associated with aging—and who are too high risk to undergo mitral valve surgery.
According to Ms. Wong, results from the COAPT trial could lead to expansion of the use of MitraClip to many more patients with mitral regurgitation. “This could represent a meaningful difference for many people, because MitraClip is so much less invasive than surgery.”
For further information, visit www.columbiaheartvalve.org or contact the Heart Valve Center at 212.342.0444.
* Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy (COAPT) for High Surgical Risk Patients Trial: Use of the Mitraclip system® in treating both high risk and prohibitive risk surgical candidates with moderate to severe, centralized mitral regurgitation. Principal Investigator: William A. Gray, MD.