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Clinical Trials

TAVR for Low-Risk Patients
The CoreValve Pivotal trial compared surgical aortic valve replacement with transcatheter aortic valve replacement (TAVR) in high-risk patients. Cardiac physicians at St. Francis were part of this ground-breaking research, which led to U.S. Food and Drug Administration approval of TAVR for patients at high surgical risk for aortic valve replacement.

Now, physicians at St. Francis are participating in a trial comparing TAVR with surgical aortic valve replacement (AVR) in low surgical risk patients. Until now, TAVR had been approved only for patients with high/extreme risk and more recently intermediate surgical risk patients.

The current randomized, prospective trial will span more than five years and will study whether the less invasive approach with TAVR is comparable or equal to surgical aortic valve replacement in low-risk patients.

A number of patients at St. Francis will participate in the trial, which is recruiting over 1,000 patients from 80 sites throughout the U.S., Canada, and New Zealand.

The CoreValve Evolut® System
This recapturable, self-expanding TAVR System, allows for optimal device placement. The device is typically inserted via an artery in the leg and then guided through the arteries in the heart. Once in place, the device expands and takes over the original valve’s function, enabling oxygen-rich blood to flow efficiently out of the heart.

The hope is that the trial will prove a compelling alternative to surgical valve replacement for more and more patients with aortic valve stenosis.

St. Francis Hospital has been a leader in the offering of TAVR, with physicians having performed more than 1,100 TAVR cases since 2011. Each year, the number of TAVR cases performed has grown rapidly; in 2016 alone, 450 TAVR cases were completed at St. Francis. The growth of TAVR has continued as more patients and physicians embrace the concept, become aware of this less invasive approach, and see positive outcomes.