Englewood Health Selected as Clinical Trial Site for Expanding TAVR Applications

Trial investigates TAVR suitability in patients with moderate aortic stenosis

February 1, 2024 — As a national leader in transcatheter aortic valve replacement (TAVR) to treat aortic stenosis (AS), Englewood Health will enroll eligible patients in a new clinical trial looking at expanded use of TAVR for treating patients with less severe aortic valve disease.

Englewood Health is a clinical trial site for the EXPAND II Pivotal Trial, the first randomized clinical study evaluating the self-expanding, supra-annular Evolut™ TAVR platform in patients with moderate, symptomatic AS, a population outside of the current guidelines and indications for TAVR.

The EXPAND II Pivotal Trial will enroll patients at up to 100 sites globally, including at Englewood Health, home to one of the most experienced TAVR programs in the New York metro area.

“We are enrolling patients into this important clinical trial as part of our commitment to provide the most advanced cardiac care to our patients,” says Adam Arnofsky, MD, chief of cardiothoracic surgery at Englewood Health. “Our team continuously seeks to improve heart procedures and outcomes for patients here in New Jersey and to contribute to the global scientific body of knowledge on cardiovascular treatments.”

The Evolut TAVR platform is approved worldwide for treating severe symptomatic AS. TAVR is not currently included in the treatment guidelines for moderate AS, however data from this study may be used to support expanded indications for the Evolut TAVR platform.

“Our goal is that by participating in this clinical trial, our patients will ultimately benefit from expanded treatment options,” says Joseph De Gregorio, MD, executive director of Cardiovascular Services at Englewood Health. “Interventional cardiologists and cardiothoracic surgeons at Englewood Health are honored to be leading the potential expanded use of this minimally invasive procedure.”

“Twice as many patients have moderate stenosis of the aortic valve as those with severe stenosis,” says Ramin Hastings, MD, medical director of the Structural Heart and Valve Program at Englewood Health and an interventional cardiologist. “With the availability of TAVR, a minimally invasive treatment option that may lead to faster recoveries than traditional cardiac surgery, the question arises whether we should consider earlier intervention for aortic stenosis patients to enhance their long-term health.”

Englewood Health was one of the first hospitals in the country to begin offering TAVR following its FDA approval in 2011. To date, Englewood Health’s Structural Heart and Valve Program has performed over 1,500 TAVR procedures, with the best possible success rates and outcomes for our patients.

The Society of Thoracic Surgeons has recognized Englewood Health with a 3-star rating—the highest possible quality rating—for transcatheter aortic valve replacement (TAVR) and the hospital has achieved transcatheter valve certification from the American College of Cardiology, an honor bestowed for excellence in TAVR procedures.

Englewood Health is actively enrolling patients in the EXPAND II Pivotal Trial.