By Keith Jones, Abrazo Health spokesman
Abrazo Arizona Heart Hospital, 1930 E. Thomas Road, Phoenix, staff is participating in the EXPAND II Pivotal Trial.
This is the first randomized clinical study evaluating the Evolut transcatheter aortic valve replacement platform in patients with moderate, symptomatic aortic stenosis. Abrazo Arizona Heart Hospital, a satellite of Abrazo Arrowhead Campus, 18701 N. 67th Ave., Glendale, is one of the select sites worldwide to participate in the study. More than 2 million patients live with moderate aortic stenosis in the U.S. 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 can 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.
Abrazo Arizona Heart Hospital has a long history of advancing cardiovascular research and bringing innovations in care to Arizona, according to hospital CEO Stephen Garner. Abrazo physicians participated in numerous clinical studies, including early research on transcatheter aortic valve replacement.
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 U.S.
The study will evaluate for the first time the Medtronic Evolut FX TAVR System and guideline-directed management and therapy compared to GDMT alone in patients with moderate, symptomatic aortic stenosis. The data can be used to support future regulatory submissions to expand the current indications for the Evolut TAVR platform.
Visit ClinicalTrials.gov (NCT05149755) or AbrazoHealth.com.
