Volta Medical's RESTART Trial Shows Promising Findings for AI Solutions in Recurrent Atrial Fibrillation
- Volta Medical's artificial intelligence (AI) solution demonstrated 83% freedom from atrial fibrillation (AF) at 12 months after a single procedure in patients with recurrent AF and isolated pulmonary veins following prior ablation
MARSEILLE, France, Feb. 3, 2026 /PRNewswire/ -- Volta Medical, committed to revolutionizing care for underserved complex AF patients with breakthrough AI solutions, announced results from the RESTART trial, published in Heart Rhythm. This study demonstrates positive outcomes for patients with recurrent AF and isolated pulmonary veins who underwent ablation using Volta's AI solution for spatio-temporal dispersion mapping, a population who has historically had suboptimal outcomes. 1,2 Findings from the trial will be presented at AF Symposium on Thursday February 5, 2026, at 8:30am ET in Boston, MA by principal investigator Dr. John Hummel MD, FHRS, Director of Electrophysiology at the Ohio State University Wexner Medical Center.
The RESTART trial was an interventional, prospective, single-arm, multicenter clinical trial. Patients with previous catheter or surgical ablation for AF were enrolled. Patients with documented reconnected pulmonary veins during the procedure were prospectively withdrawn from the trial. Follow-up included 3-6- and 12-month visits. The primary endpoint of the study was freedom from documented AF at 12-months after a single AI-guided repeat ablation procedure.
The RESTART trial (NCT05477147) is the first prospective, multicenter study to evaluate this innovative approach. Key findings include:
- 83% freedom from atrial fibrillation at 12 months after a single procedure when using Volta's AI solution.
- 70% freedom from any atrial arrhythmia after one procedure, compared to 29%–37% success rates reported in prior studies using empirical strategies in similar patient populations. 1,2
- 45% of enrolled patients had undergone two or more prior ablations, reflecting a highly complex and treatment-resistant cohort.
- Right atrial dispersion identified in nearly 60% of patients, underscoring the importance of bi-atrial mapping.
- 19.7-point improvement in quality of life as measured by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score, exceeding the five-point threshold considered clinically meaningful.3
You can access the full publication here: https://www.heartrhythmjournal.com/article/S1547-5271(26)00105-0/abstract
"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," said Dr. John Hummel. "The RESTART trial shows the potential of Volta's AI solution."
"With more than 7 million people living with atrial fibrillation in the US today, the need for better treatment options has never been greater, 4" 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."
The RESTART trial involved one of the most challenging patient populations in atrial fibrillation care, individuals with recurrent AF despite confirmed durable pulmonary vein isolation. 1,2 These patients have historically faced poor success rates with empirical strategies. 1,2 By leveraging Volta Medical's AI solution, RESTART demonstrates that even in this highly complex group, personalized, data-driven therapy has the potential to deliver improved outcomes.
About Atrial Fibrillation
The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.5 It is estimated that 7 million patients in the US are living with AF.4,5 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition.
About Volta Medical
Volta Medical is a health technology company advancing the use of AI to transform the treatment of complex cardiac arrhythmias. Founded in 2016 in Marseille, France, by three physicians and a data scientist, Volta's mission is to improve outcomes for patients with AF by developing cutting-edge, data-driven solutions trained on vast procedural datasets.
The company's flagship product, AF-Xplorer™ II, is a next-generation digital AI companion designed to assist electrophysiologists with the real-time identification of spatio-temporal dispersed electrograms (EGMs) during AF and atrial tachycardia procedures. Engineered for versatility, AF-Xplorer II integrates seamlessly with leading AF mapping and recording systems and is compatible with the most common ablation modalities. The solution is both U.S. FDA 510(k) cleared and European CE Marked.
To support awareness and education, Volta Medical created the AI for Persistent AF Care program to connect patients, caregivers, and providers with resources about AF and AI-guided treatment. For more information, visit www.aiforafib.com.
Media Contact
Molly Megna, Sr. Marketing Manager
Volta Medical
[email protected]
References
- Sciacca V, Fink T, Eitel C, et al. Repeat catheter ablation in patients with atrial arrhythmia recurrence despite durable pulmonary vein isolation. J Cardiovasc Electrophysiol. 2022;33:2003–2012.
- Weng W, Birnie DH, Ramirez FD, et al. Outcomes of a comprehensive strategy during repeat atrial fibrillation ablation. J Interv Card Electrophysiol. 2022;65:391–399.
- Holmes DN, Piccini JP, Allen LA, et al. Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circ Cardiovasc Qual Outcomes. 2019;12:e005358.
- Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circulation Research. 2020;127(1):4–20. doi:10.1161/CIRCRESAHA.120.316340.
- https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed January 14, 2026]
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