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VA Ann Arbor Veterans Selected to Participate in Revolutionary Heart Device Study

The research team at VAAAHS conducting the ALLAY-HF study.
From Left to Right: Sam Chirla, Lauren Herty, Doug Fulton, Sharon Thomas, Dr. Sarah Gualano, Dr. Scott Hummel, and Dr. Andrew Harris make up the research team conducting the ALLAY-HF study at VA Ann Arbor Healthcare System. Karen Belanger and Dr. Megan Joseph (not pictured) are also on the team.
By Chris Arbino, Deputy Director of Communications

Veterans under the care of VA Ann Arbor Healthcare System (VAAAHS) are participating in a new treatment for heart failure with preserved ejection fraction (HFpEF), and researchers are hopeful the new investigational device can alleviate symptoms of heart failure.

In May 2022, Alleviant Medical, the company leading the trial for the no-implant shunt in heart-failure patients, announced their results from “early feasibility clinical trials published in JACC-HF which demonstrated procedural safety, feasibility, and a promising efficacy signal through six months.” Alleviant Medical reached out to VA Ann Arbor Healthcare System to include the Veteran population in the no-implant shunt for their heart failure study called ALLAY-HF. VAAAHS’ affiliated non-profit corporation, VERAM, completed a Cooperative Research and Development Agreement with VAAAHS and Alleviant Medical in support of this public-private collaboration.

The Alleviant Medical device is inserted into a blood vessel through the leg and navigated to the heart. The device is then guided through the inner heart wall, known as the inter-atrial septum. Once the device is positioned, it securely captures the tissue within. A small pulse of energy is used to remove a small piece of the tissue, creating a new, durable passageway between the left and right atrium called the interatrial shunt. 

The new passageway reduces pressure in the left side of the heart and may reduce the symptoms of heart failure such as shortness of breath, water retention, and fatigue. Researchers are hopeful that this new investigational technique, which does not leave any implant in the body, may provide distinct advantages to the chronic heart failure population. 

Device animation: Alleviant Medical: Alleviant System Procedure Animation 

The ALLAY-HF study will determine whether the interatrial shunt can reduce cardiovascular events and improve quality of life. 

VA Ann Arbor Healthcare System is just one entity participating in the trial out of several others world-wide. Other VA systems in New York, Atlanta, and San Francisco are also participating in the study, but VAAAHS is the first VA healthcare system to successfully randomize a Veteran into this study. 

“Those suffering from heart failure are limited in their daily activities such as walking, household work, or even getting dressed,” said Sharon Thomas, RN, BSN, a research health science specialist at VA Ann Arbor Healthcare System. “Many of our Veterans experience these frustrations and are eager to find a solution. That’s why we believe Veterans can benefit from this innovation and future emerging therapies that might result from this study.”

For the Veterans that have been randomized into the study, VAAAHS’ research team who conducted the surgery will continue to monitor the Veterans progress over the next five years to see if the device works better than the control group or current heart failure treatments. 

Those researchers then share their data with Alleviant Medical, who compiles all the information about their device from around the world. Once this is completed, the company will make these results publicly available at the conclusion of their study at www.clinicaltrials.gov