St. Vincent's Enrolls Atrial Fibrillation Patients In Trial

Jacksonville FL

28 March, 2022

6:59 PM

Description

Press release from the JAX Chamber: March 28, 2022 Volta VX1 is a new medical AI software designed to help cardiologists identify cardiac abnormalities in patients undergoing ablation treatment for persistent, drug-resistant AF. It is cleared by the U.S. Food and Drug Administration (FDA) and CE-certified by the European Union. AF, characterized by an irregular heartbeat, can lead to more serious health issues such as heart failure and stroke. During AF ablation, a specialized cardiologist known as an electrophysiologist inserts catheters through the blood vessels into the heart to burn or freeze the tissue causing abnormal electrical signals in the upper chamber, or atrium. The procedure creates scarring that restores a normal heartbeat. The VX1 system analyzes electrical signals measured during the procedure and identifies abnormalities in real-time. The international, randomized, controlled TAILORED-AF clinical trial will evaluate the outcomes of VX1-guided ablation versus standard ablation. "This technology has already transformed how I treat patients with this type of atrial fibrillation," said Dr. Saumil Oza, cardiologist at Ascension St. Vincent's Riverside. "I've been able to treat patients who have previously not been helped by a standard ablation. It can also improve outcomes because we can precisely pinpoint the optimal ablation locations for each patient." One of the hospital's first trial patients, Steven Preiss, age 67, says he's relieved after having the procedure. "Now, I can walk around no problem. I'm not gasping for breath, my heart's not racing, and it's really good now," says Preiss. "I feel 100 percent better. This experience means the world to me." Ascension St. Vincent's is actively recruiting patients from across Northeast Florida and Southeast Georgia for the TAILORED-AF trial. Potential patients may call (904) 308-5761 to learn more, see if they qualify, and schedule an appointment. TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024. About Volta Medical Volta Medical is a health tech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta's overarching goal is to significantly improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices based on large databases of procedural data with the highest standards of data protection. Founded by three physicians and a data scientist in 2016 in Marseille, France, Volta's first product, VX1, assists cardiologists in the real-time identification of specific abnormal electrograms, known as dispersed electrograms. For more information, visit the company's website at www.volta-medical.com. Allison Dukes, Connect Agency 608-616-2713 [email protected] This press release was produced by the JAX Chamber. The views expressed here are the author's own.