Morristown Medical Center Randomizes First Patient in World to New Study to Evaluate Treatment for Asymptomatic Severe Aortic Stenosis

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, and prevent further heart deterioration.

Morristown Medical Center, part of Atlantic Health System, today announced it has randomized the first patient in the world to the EARLY TAVR (Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis) trial, approved for commencement by the U.S. Food and Drug Administration.

Dr. Philippe Genereux, an interventional cardiologist and Co-Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center, serves as the trial’s principal (lead) investigator.

Traditionally, patients with severe aortic stenosis (AS)—a narrowing of the aortic valve in the heart that keeps it from opening fully—who do not yet have symptoms (asymptomatic), are regularly followed and monitored by their cardiologist, and treatment is not initiated until they become symptomatic. However, many elderly patients with asymptomatic severe AS can develop irreversible heart damage or even die while waiting for symptoms to appear. The EARLY TAVR trial will evaluate whether there is benefit from replacing the aortic valve via a minimally invasive, catheter-based procedure (called a transcatheter aortic valve replacement) before patients develop symptoms (shortness of breath, dizziness, fainting, or angina) as compared to the standard of care of watching the patient until symptoms develop.

“The EARLY TAVR trial is an incredibly important trial for the more than 2.5 million people who suffer from aortic stenosis because it may…

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