ABILENE, Texas (KTAB/KRBC) – Hendrick Health has enrolled two patients in the U.S. for heart failure clinical trial. One patient has already met the eligibility criteria and went through the blinded procedure to demonstrate the safety and effectiveness of the Alleviant System (ALLAY-HF). The second patient is working through the eligibility process.

In March, Hendrick became the first study site in the country for this global clinical trial with the purpose to evaluate the safety and efficacy of Alleviant’s No-Implant Interatrial Shunt Creation. The study is for patients suffering from heart failure, specifically with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction who still have symptoms after medical therapy.

“Many heart failure patients are left without options if they do not experience relief of their symptoms after significant lifestyle changes and complex medication regimens,” said Dr. Mark Lawrence, an interventional cardiologist at Hendrick Health. “We are excited to explore the potential of percutaneous left atrial decompression to give these patients a chance at a better quality of life without the risk of leaving an implant behind in the heart.”

The trials are randomized and double-blinded, meaning the participants and the researchers do not know if the patient had the treatment until the trial ends. This makes the results less likely to be biased or impacted by factors not related to the test.

The medical device is delivered through a minimally-invasive procedure that does not leave a permanent implant behind. The procedure creates a connection between the left and right atrial chambers of the heart. It is intended to reduce excess pressure in the heart, which may lower symptoms of heart failure such as swelling, shortness of breath and fatigue.