July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, 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.
Philippe Genereux, M.D., 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. The study is a U.S. Food and Drug Administration approved inventigational device exemption (IDE) trial.
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,” Genereux explained. “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 disease,” said Linda D. Gillam, M.D., 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 helps 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. The study will enroll 1,000 patients in 65 cardiovascular centers.
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. According to Edwards Lifesciences, global transcatheter heart valve therapy (THVT) sales rose 29 percent to $432 million in the past year. In the United States, sales grew by 38 percent. Edwards said cardiac surgeons and interventional cardiologists are now implanting the company’s Sapien 3 TAVR devices at more than 500 hospitals in the U.S.
For more information: www.atlantichealth.org/valveresearch
Related TAVR and Sapien 3 Content:
FDA Expands Sapien TAVR Valve Indication to Intermediate-Risk Patients
FDA Expands CoreValve TAVR Valve Use for Intermediate Risk Patients
VIDEO: TAVR Stands Equal to Surgical Valve Replacement
VIDEO: The State of TAVR in 2016
Early Quality of Life Improvements Sustained for Intermediate-Risk Patients Treated with Edwards Transcatheter Valves