Abrazo Arizona Heart Hospital joins 3 clinical trials aimed at helping patients with advanced cardiovascular conditionsNov 4, 2016
PHOENIX (NOV. 4, 2016) – Abrazo Arizona Heart Hospital is participating in three major clinical trials aimed at advancing care for Americans with complex cardiovascular conditions.
The hospital is one of 80 sites to participate in the expanded indication trial for the CoreValve Evolut R System, the first and only next-generation recapturable, self-expanding Transcatheter Aortic Valve Replacement (TAVR) system commercially available in the United States.
The trial will include 1,200 patients with severe aortic stenosis – a narrowing of the aortic valve that obstructs blood flow to the heart and the rest of the body – who have a less than 3 percent risk of operative mortality, as determined by a heart team. Low-risk patients will be enrolled with 1:1 randomization to receive the Evolut R System or undergo open-heart surgery (surgical aortic valve replacement, or SAVR). These are patients who are at a lower risk for conventional open heart or bypass surgery than patient who are at a higher risk because they are too weak or have other risk factors making them inoperable for conventional surgery. The Investigational Device Exemption (IDE) is an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke.
The trial has a two-year endpoint and allows for a one-year analysis for early FDA submission. Additionally, the trial will include a sub-study of leaflet mobility in 400 patients.
Clinical trial involvement brings new technology with standardized controls and oversight to assure optimal outcomes with high level of patient protections.
“We are thrilled to join Medtronic in understanding the benefits of TAVR for a great number of the estimated 1.5 million Americans who suffer from aortic stenosis,” said Dr. Timothy Byrne, physician executive director of cardiac services for Abrazo Community Health Network.
Along with the TAVR study, Abrazo Arizona Heart Hospital is participating in two other clinical trials.
Among them are:
PARACHUTE IV, a randomized pivotal U.S. trial of the minimally invasive catheter-based Parachute® Ventricular Partitioning Device for the treatment of heart failure. After a heart attack, some heart failure patients experience enlargement of their left ventricle, causing a decrease in cardiac output and resulting in shortness of breath and other heart failure symptoms. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function. PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 560 patients with ischemic heart failure at up to 80 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life, and hemodynamic measures by echocardiography.
Baroreflex Activation Therapy for Heart Failure (BeAT-HF), a Phase III randomized, controlled clinical trial that studies the safety and efficacy of BAROSTIM THERAPY, the only therapy designed to reduce sympathetic nervous system activity while restoring parasympathetic activity for the treatment of heart failure. The trial will randomize 480 patients who suffer from heart failure with a reduced ejection fraction and who have no additional treatment alternatives available. BeAT-HF has achieved Expedited Access Pathway (EAP) designation by FDA for its focus on this unmet clinical need.
Participation in these clinical trials is part of Abrazo Arizona Heart Hospital’s bigger plan to continue its legacy of excellence in cardiovascular care in Arizona, across the Southwest and throughout the nation. The hospital has established six specialty cardiac and vascular institutes, expanded its services and become a training ground for cardiologists nationwide.
“Unlike many other areas of medicine, cardiology continues to progress at a breakneck pace. We are excited to be at the forefront of new testing, treatments and technologies that will help patients not only live longer, but also remarkably better,” Dr. Byrne said.