Atlantic Health, selected to lead global clinical trial on aortic stenosis, enrolls 1st patient

Morristown Medical Center announced this week that it has enrolled the first patient in the world in the PROGRESS clinical trial — a potentially groundbreaking study that could help the care for the more than 2.5 million people who suffer from aortic stenosis.

PROGRESS stands for a Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement, a treatment that has been given the approval of the U.S. Food and Drug Administration.

Traditionally, patients with aortic stenosis — a narrowing of the aortic valve in the heart that keeps it from opening fully, are regularly followed and monitored by their cardiologist, with current cardiology society guidelines recommending valve replacement only when they reach a critical or severe degree of stenosis.

However, some patients with moderate AS may develop irreversible heart damage or even die before AS becomes severe. The PROGRESS trial will evaluate whether there is benefit from replacing the aortic valve via a minimally invasive, nonsurgical, catheter-based procedure (called a transcatheter aortic valve replacement, or TAVR) before patients progress to a severe degree of AS, as compared to the standard of care of clinical surveillance.

The PROGRESS trial will enroll patients aged 65 and older who have been diagnosed with moderate aortic stenosis with symptoms or already established signs of cardiac damage. Participants will be randomized to receive a TAVR with the Edwards SAPIEN 3/Ultra heart valve, or standard of care clinical surveillance. Up to 750 patients will be enrolled worldwide. Patients in this study will be followed carefully up to 10 years by a team of heart valve experts.

Dr. Philippe Genereux, an interventional cardiologist, and director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center, serves as the trial’s principal investigator. Morristown Medical Center is the flagship hospital of Atlantic Health System.

“The PROGRESS trial is extremely important trial for the more than 2.5 million people who suffer from aortic stenosis,” Genereux said. “It may change the current paradigm of waiting until patients reach a severe or critical degree of stenosis before replacing their valves.

“The progression of aortic stenosis is unpredictable, and there may be a price to pay for waiting to treat — the goal of early intervention with valve replacement is to preserve the heart’s function, prevent further heart deterioration and, in some cases, prevent death.”

Genereux and Atlantic Health were chosen to lead this large international study over others at big academic medical centers in New York City and elsewhere.

Dr. Linda Gillam, the Dorothy and Lloyd Huck Chair of Cardiovascular Medicine at Morristown Medical Center/Atlantic Health System, said the study shows the depth of coverage at Atlantic Health.

“We are excited to randomize the first patient to the PROGRESS trial,” she said. “This illustrates one of the many benefits of research at Morristown Medical Center and Atlantic Health System — giving our patients access to new approaches to their care.”