Under the leadership of AdventHealth Heart, Lung and Vascular Institute interventional cardiologist Rohit Bhatheja, MD, MBA, FACC, FSCAI, AdventHealth Orlando became the first in Central Florida to randomize a patient in the ALLAY-HF clinical trial on January 15, 2024. The study is a global, double-blinded, randomized, sham-controlled trial to demonstrate the safety and effectiveness of the Alleviant System for the treatment of chronic heart failure through left atrial decompression.
The ALLAY-HF trial targets patients suffering from heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction who have heart failure symptoms despite appropriate medical therapy. The Alleviant System is a novel technology intended to address these patients’ needs through decompression of the left atrium using a minimally invasive, percutaneous approach without leaving behind any implant.
“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,” explains Dr. Bhatheja. “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.”
How the Alleviant System Works
The Alleviant System was granted U.S. FDA Breakthrough Device Designation in 2021. It is an investigational medical device that creates a connection between the left and right atrial chambers of the heart through a single procedure without leaving a permanent implant behind. The procedure is intended to reduce excess pressure buildup within the heart, which may reduce symptoms of heart failure such as shortness of breath, fatigue, weakness and swelling in the legs or belly.
About Chronic Heart Failure
Chronic heart failure (CHF) is a progressive disease that affects 26 million patients worldwide and is the leading cause of hospitalizations worldwide, resulting in a significant economic burden to the healthcare system. Common symptoms of CHF include shortness of breath during exertion (or at rest), inability to perform daily activities (walking, climbing stairs), fatigue and weakness, and swelling in the legs, ankles, feet or belly. Despite medications available for management of heart failure, many patients still experience debilitating symptoms, frequent hospitalization and reduced quality of life.