Volta Medical Declares Completion Of Affected person Enrollment In TAILORED-AF Medical Trial For Remedy Of Atrial Fibrillation
Volta Medical, a pioneering well being expertise firm growing synthetic intelligence (AI) options to help electrophysiologist physicians in treating advanced cardiac arrhythmias akin to atrial fibrillation (AF), as we speak introduced the completion of affected person enrollment within the randomized managed medical trial, TAILORED-AF, evaluating VX1-guided ablation in comparison with a ‘commonplace of care’ anatomical ablation method.
The corporate’s lead product, VX1, is the primary commercially out there AI decision-support software program to assist information physicians with identification and real-time annotation of distinctive abnormalities (so known as “dispersed electrograms“) on 3D anatomical and electrical maps of the guts. This expertise finally might result in optimized catheter-ablation procedures for advanced arrhythmias, together with persistent AF.
“Atrial fibrillation is the most typical coronary heart rhythm disturbance in adults and the necessity for extra exact therapies is critical,” stated Professor Isabel Deisenhofer, MD, of German Coronary heart Middle in Munich, Germany and first investigator for the trial. “Whereas catheter ablation is well-established as an necessary remedy for AF, a extra constant commonplace of care is required for its extra progressed illness state, often called persistent AF. VX-1 has the potential to satisfy that want by aiding electrophysiologists in delivering profitable outcomes with every affected person ablation.”
The TAILORED-AF medical trial is a global, multicenter, randomized managed examine designed to verify the medical significance of VX1 and lay the groundwork for establishing VX1 as a brand new commonplace of look after persistent AF ablation. The first endpoint is freedom from documented AF episodes lasting longer than 30 seconds, with or with out anti-arrhythmic medication (AADs), 12 months after a single index ablation process. Secondary endpoints embrace absence of AF and/or atrial tachycardia (AT) episodes after a 12-month interval, following a number of procedures, in addition to security.
“We’re dedicated to serving to physicians use EGM-assessment software program to information ablation and offering one other medical device to help the absolute best outcomes for sufferers,” stated Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “We’re excited to finish affected person enrollment on this 26-site managed trial and proceed learning our VX1 platform, and stay up for reporting the leads to 2024 to supply electrophysiologists extra important, life-changing care choices to sufferers.”
In regards to the TAILORED-AF Trial
TAILORED-AF is a global, multicenter trial designed to find out if a tailor-made VX1 AI software-guided ablation technique focusing on areas of spatiotemporal dispersion together with pulmonary vein isolation (PVI) is superior to a standard anatomical ablation technique focusing on PVI alone for the remedy of persistent AF. The first endpoint of the examine is the absence of documented AF episodes > 30 seconds, with or with out anti-arrhythmic medication (AADs), 12 months after a single index ablation process. Secondary endpoints embrace absence of AF and/or atrial tachycardia (AT) episodes after a 12-month interval, following a number of procedures, in addition to security. Volta Medical expects outcomes from the TAILORED-AF trial in 2024.