Doctors at Abrazo Arizona Heart Hospital are participating in the EXPAND II Pivotal Trial, the first randomized clinical study evaluating the Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate, symptomatic aortic stenosis.
Abrazo Arizona Heart Hospital, a satellite of Abrazo Arrowhead Campus, is one of the select sites worldwide to participate in the study. More than 2 million patients live with moderate aortic stenosis in the United States. TAVR is not currently included in the guidelines for treating these patients.
Aortic stenosis occurs when the heart’s aortic valve narrows due to calcium buildup. It is a progressive disease, meaning it gets worse over time and can be debilitating, costly and deadly. TAVR is a minimally invasive procedure to reopen the diseased aortic valve by inserting a prosthetic valve.
Data from the study may be used to support future applications to expand use of the TAVR procedure in a greater number of patients. The EXPAND II Pivotal Trial will enroll up to 650 patients globally to study the safety and efficacy of the procedure in patients with moderate, symptomatic aortic stenosis.
“It’s really a privilege and an honor for Abrazo Arizona Heart Hospital to be a part of many pioneering advances in cardiovascular medicine,” said Dr. Timothy Byrne, co-principal investigator at Abrazo Arizona Heart Hospital. “Most importantly, we are proud to participate in a clinical trial to study potential benefits of TAVR among a broader patient population.”
Abrazo Arizona Heart Hospital has a long history of advancing cardiovascular research and bringing innovations in care to Arizona. Abrazo physicians have participated in numerous clinical studies including early research on transcatheter aortic valve replacement.
“We are pleased to participate in the EXPAND II Pivotal Trial as part of our ongoing commitment to providing advanced care to the thousands of patients in our community living with aortic stenosis,” co-principal investigator Dr. Merick Kirshner said.
The Evolut TAVR platform is currently approved for the treatment of symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the United States.
The study will evaluate for the first time the Medtronic Evolut FX TAVR System and guideline-directed management and therapy (GDMT) compared to GDMT alone in patients with moderate, symptomatic aortic stenosis.
The data may be used to support future regulatory submissions to expand the current indications for the Evolut TAVR platform. For more information on the study design, visit clinicaltrials.gov.
For more information about Abrazo Health hospitals, take a free heart health risk assessment or to find a doctor, visit abrazohealth.com.