Volta Medical has announced results from the RESTART trial, published in the journal Heart Rhythm, that demonstrate positive outcomes for patients with recurrent atrial fibrillation (AF) and isolated pulmonary veins who underwent ablation using the company’s artificial intelligence (AI) solution for spatiotemporal dispersion mapping—a population that “has historically had suboptimal outcomes”.
Findings from the trial were also presented last week at the AF Symposium (5–7 February 2026, Boston, USA) by principal investigator John Hummel (State University Wexner Medical Center, Columbus, USA).
“Patients with recurrent atrial fibrillation and isolated pulmonary veins represent one of the most frustrating populations we treat,” Hummel commented. “The RESTART trial shows the potential of Volta’s AI solution. Many of these patients have already undergone multiple procedures and are told there are no good options left.”
RESTART was an interventional, prospective, single-arm, multicentre clinical trial enrolling patients with previous catheter or surgical ablation for AF. Patients with documented reconnected pulmonary veins during the procedure were prospectively withdrawn from the trial. Follow-up included visits at 3–6 and 12 months. The primary endpoint of the study was freedom from documented AF at 12 months after a single AI-guided repeat ablation procedure.
Key findings of the trial include an 83% rate of freedom from AF at 12 months after a single procedure when using Volta’s AI solution, as well as 70% freedom from any atrial arrhythmia after one procedure compared to success rates of 29–37% reported in prior studies using empirical strategies in similar patient populations, the company claims.
Volta also notes in a recent press release that some 45% of enrolled patients had undergone two or more prior ablations, reflecting “a highly complex and treatment-resistant cohort”—while right atrial dispersion was identified in nearly 60% of patients, “underscoring the importance of bi-atrial mapping”.
Finally, the company reports a 19.7-point improvement in quality of life as measured by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score within the RESTART trial, which exceeds the five-point threshold that is considered clinically meaningful.
“With more than seven million people living with atrial fibrillation in the USA today, the need for better treatment options has never been greater,” added Volta chief executive officer (CEO) and co-founder Théophile Mohr-Durdez. “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.”
