St. Francis Only LI Hospital in Heart Valve Clinical Trial

Catholic Health’s St. Francis Hospital & Heart Center® is always seeking new, improved options for cardiac patients, which is why the hospital’s cardiac team is involved in a clinical trial to determine the safety and effectiveness of a device designed to replace a faulty tricuspid valve in the heart through a minimally invasive procedure.

The TRISCEND II Pivotal Trial is evaluating the Edwards EVOQUE™ tricuspid valve replacement system. The device replaces a regurgitant—leaky—tricuspid heart valve through a minimally invasive procedure, where a small incision in the leg is made to access the heart and perform the procedure. 

Tricuspid regurgitation (TR) occurs when the heart’s tricuspid valve does not fully close. The condition occurs typically when the valve has dilated, or stretched, and its leaflets do not shut tightly. As a result, blood flows backward within the heart, causing symptoms such as shortness of breath with activity and swelling in the abdomen, legs or veins in the neck. 

The St. Francis team taking part in the trial is led by the Director of Interventional Cardiovascular Procedures and Co-Director of the Heart Valve Center George Petrossian, MD, and Chairman of the Department of Cardiothoracic and Vascular Surgery Newell Robinson, MD. The hospital’s participation in the trial is made possible through its Master Research Agreement with Edwards Lifesciences.

To date, two patients have been treated at St. Francis Hospital & Heart Center.

Dr. Petrossian and Dr. Robinson said the EVOQUE valve gives cardiologists an option for treating TR and provides patients with faster recovery times compared to open heart surgery. 

“Participating in the TRISCEND II Pivotal Trial allows us to be at the forefront in the use of new technology and an advance in treatment,” said Dr. Petrossian. “The results from our initial patients have been very promising and over time the new valve could provide many patients a solution that will allow them to live a long and healthy life.”

“This valve allows us to treat a serious heart condition in a way that is much less invasive to the patient,” Dr. Robinson said. “This will also mean shorter hospital stays and recovery times for patients.”

Patient screening for participants in the Triscend II Pivotal clinical trial is ongoing. Those interested may call St. Francis Hospital at (516) 562-6790. 

For more information on the St. Francis Heart Center, available across Long Island, please call (866) MY-LI-DOC or visit chsli.org.