Results from the RESTART trial, published in Heart Rhythm, demonstrated positive outcomes for patients with recurrent AFib and isolated pulmonary veins who underwent ablation using Volta’s AI solution.
The company plans to share findings this week at the AF Symposium in Boston.
Volta’s AI-powered AF-Xplorer platform uses AI to analyze real-time electrograms and help electrophysiologists identify specific types of abnormal electrical activity.
RESTART marked the first prospective, multicenter study to evaluate Volta’s approach. It had a primary endpoint of freedom from documented AFib at 12 months after a single AI-guided repeat ablation procedure. The study included 45% of enrolled patients who underwent two or more prior ablations, reflecting a highly complex, treatment-resistant cohort.
Investigators reported 83% freedom from AFib at 12 months after a single procedure. They reported 70% freedom from any atrial arrhythmia after one procedure. That compares to 29%-37% success rates in prior studies using empirical strategies in similar populations. Investigators saw right atrial dispersion in nearly 60% of patients, underscoring the importance of bi-atrial mapping.
Volta reports a 19.7-point improvement as measured by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, exceeding the five-point threshold considered clinically meaningful.
“With more than 7 million people living with atrial fibrillation in the US today, the need for better treatment options has never been greater,” said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. “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.”
