Trial may change treatment paradigm, save heart muscle
MORRISTOWN, NJ – 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 provide an answer to the frequent dilemma cardiologists face about how they should treat severe aortic stenosis, even though patients have no symptoms,” said Genereux. “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 case, death.”
“As a nationally recognized leader in cardiology and cardiovascular surgery, Atlantic Health System is committed to both prolonging and improving the quality of life for patients with heart issues or disease,” said Linda D. Gillam, MD, MPH, The Dorothy and Lloyd Huck Chair of Cardiovascular Medicine at Morristown Medical Center/Atlantic Health System. “Our participation in clinical trials, like EARLY TAVR, not only ensures our patients have access to new treatments before they are approved or available to the general public, but ensures our clinicians remain on the cutting edge of medicine with access to the latest medications, devices, and technology.”
About the EARLY TAVR Trial
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis (EARLY TAVR) is a randomized, controlled, multi-center clinical trial study. Patients aged 65 and older diagnosed with asymptomatic, severe aortic stenosis will be randomized to receive a transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 heart valve, or standard of care clinical surveillance.
Patients will be randomized (TAVR or surveillance) based on their ability to perform a treadmill stress test, as well as other factors. Those patients with a positive treadmill stress test or who do not meet other factors for randomization may be followed in a registry for data collection on subsequent treatment and mortality, as applicable.
The EARLY TAVR trial is sponsored by Edwards Lifesciences.
About Aortic Stenosis (AS) and Transcatheter Aortic Valve Replacement (TAVR)
Aortic stenosis (AS), one of the most common and serious valve diseases, is a narrowing of the aortic valve opening, which restricts blood flow from the left ventricle of the heart to the aorta. Symptoms of AS include loss of breath, chest pain such as pressure or tightness of the chest region, fainting, feelings of a heavy, pounding heart, decreased physical activity or an unusual sound heard between heartbeats known as a heart murmur. For patients considered intermediate or high risk for surgical aortic valve replacement, TAVR is an FDA-approved, minimally invasive surgical procedure to replace an aortic valve that has narrowed and fails to properly open.
About Clinical Trials at the Gagnon Cardiovascular Institute at Morristown Medical Center
The Gagnon Cardiovascular Institute at Morristown Medical Center, part of Atlantic Health System, was the first hospital in New Jersey to offer TAVR for aortic stenosis, and treats more valve patients than any other hospital in New Jersey. Because of our volume and trusted, earned credibility with the sponsors of the trials—pharmaceutical, biotech, or medical device companies—we are proud to be able to offer a number of clinical trials for the treatment of valvular disease. We are actively participating in trials for aortic, mitral and tricuspid valves.
Clinical trials offer patients access to the latest treatment advancements. Though participation in a clinical trial may be a risk, Atlantic Health System works closely with the United States Food and Drug Administration to ensure patients who participate in clinical trials are watched closely by their doctor and medical team to ensure their safety. Atlantic Health System’s internal review board which oversees human research subject protection also closely evaluates the trials to ensure they have already been well-established in safety trials before allowing them to begin on any of our premises.
For more information on our current trials for patients with aortic stenosis, heart failure, or cardiomyopathy, please visit www.atlantichealth.org/valveresearch, or call the Valve Center at Morristown Medical Center at (973) 971-7001.