Medical Device News Magazine

Friday, March 31, 2023

Volta Medical Announces Completion of Patient Enrollment in TAILORED-AF Clinical Trial for Treatment of Atrial Fibrillation

irst randomized controlled clinical trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches to treat persistent atrial fibrillation. International, multi-center trial involving 26 sites, 374 patients is expected to report results in 2024.

Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologist physicians in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced the completion of patient enrollment in the randomized controlled clinical trial, TAILORED-AF, evaluating VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach.

The company’s lead product, VX1, is the first commercially available AI decision-support software to help guide physicians with identification and real-time annotation of unique abnormalities (so called “dispersed electrograms“) on 3D anatomical and electrical maps of the heart. This technology ultimately may lead to optimized catheter-ablation procedures for complex arrhythmias, including persistent AF.

“Atrial fibrillation is the most common heart rhythm disturbance in adults and the need for more precise therapies is significant,” said Professor Isabel Deisenhofer, MD, of German Heart Center in Munich, Germany and primary investigator for the trial. “While catheter ablation is well-established as an important treatment for AF, a more consistent standard of care is needed for its more progressed disease state, known as persistent AF. VX-1 has the potential to meet that need by assisting electrophysiologists in delivering successful outcomes with each patient ablation.”

The TAILORED-AF clinical trial is an international, multicenter, randomized controlled study designed to confirm the clinical significance of VX1 and lay the groundwork for establishing VX1 as a new standard of care for persistent AF ablation. The primary endpoint is freedom from documented AF episodes lasting longer than 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.

“We are committed to helping physicians use EGM-assessment software to guide ablation and providing another clinical tool to support the best possible outcomes for patients,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “We are excited to complete patient enrollment in this 26-site controlled trial and continue studying our VX1 platform, and look forward to reporting the results in 2024 to provide electrophysiologists more essential, life-changing care options to patients.”

About the TAILORED-AF Trial
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.

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
Subscribe to Medical Device News Magazine

A New Study Suggests Energy4Life’s Bioenergetic Wearable Device May Have Positive Effects on Cellular Membrane

“Our bioenergetic wearables are designed to communicate directly to the body, thus triggering its self-repair system,” said Harry Massey, founder and CEO of Energy4Life. “Digitized biological information allows you to help turn on the body's self-repair system – impacting the physics of the body - which in turn directs all other activity of the body,” stated Massey.

Inspira Technologies Announces First in Human of HYLA Blood Sensor in Clinical Study

The HYLA Blood sensor is a non-invasive optical blood sensor, being developed using machine learning based algorithms to measure blood key parameters, continuously and in real-time during extracorporeal procedures including VV-ECMO, VA-ECMO and open-heart surgery.

Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients

Dr. Hamid. “We witnessed significant and progressive reverse remodeling of the left ventricle, as well as significant and sustained improvement in quality of life and functional capacity measures. These results show promise that this innovative catheter-based therapy may help broaden options for treating patients with heart failure, and we look forward to results of the pivotal study that’s underway.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy