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.