Volta Medical's RESTART Trial Shows AI-Powered Ablation Success in Recurrent Atrial Fibrillation
Volta Medical has announced promising results from its RESTART trial, published in Heart Rhythm, demonstrating the potential of its AI-powered solution in treating patients with recurrent atrial fibrillation (AF) who have isolated pulmonary vein reconnection. The trial, the first prospective, multicenter study of its kind, evaluated the effectiveness of Volta’s AI-driven spatio-temporal dispersion mapping during a single repeat ablation procedure in a challenging patient population. The RESTART trial (NCT05477147) was an interventional, prospective, single-arm, multicenter study involving patients with prior catheter or surgical ablation for AF. Those with documented reconnected pulmonary veins during the procedure were prospectively excluded. Follow-up assessments were conducted at 3, 6, and 12 months post-procedure. The primary endpoint was freedom from documented AF at 12 months after a single AI-guided ablation. Key findings show that patients with recurrent AF and isolated pulmonary vein reconnection—historically difficult to treat with suboptimal outcomes—achieved meaningful improvements using Volta’s AI solution. These results are particularly significant given that many of these patients have undergone multiple prior procedures and often face limited treatment options. Dr. John Hummel, MD, FHRS, Director of Electrophysiology at the Ohio State University Wexner Medical Center and principal investigator of the trial, emphasized the clinical impact: “Patients with recurrent atrial fibrillation and isolated pulmonary veins represent one of the most frustrating populations we treat. Many of these patients have already undergone multiple procedures and are told there are no good options left. The RESTART trial shows the potential of Volta's AI solution.” Théophile Mohr-Durdez, CEO and co-founder of Volta Medical, highlighted the broader implications: “With more than 7 million people living with atrial fibrillation in the U.S. today, the need for better treatment options has never been greater. The RESTART trial reinforces the potential of our AI solution to transform AF care. We are proud to lead the way in delivering innovative solutions that address critical gaps in care for some of the most complex cases.” Volta Medical’s flagship product, AF-Xplorer™ II, is a next-generation AI companion designed to assist electrophysiologists in real-time identification of spatio-temporal dispersed electrograms during AF and atrial tachycardia procedures. The system integrates with leading mapping and recording platforms and is compatible with common ablation technologies. It is U.S. FDA 510(k) cleared and CE Marked. The findings will be presented at the AF Symposium on Thursday, February 5, 2026, at 8:30 a.m. ET in Boston, MA. Atrial fibrillation, defined by the American Heart Association as an irregular and often rapid heart rhythm, can lead to serious complications including stroke, heart failure, and increased risk of death. Despite its prevalence, many patients remain unaware of its severity. Volta Medical continues to advance AI-driven solutions to improve outcomes for patients with complex arrhythmias and to expand access to personalized, data-informed care.
