Volta Medical put forward new data showing its artificial-intelligence-guided ablation procedures were able to improve patients’ atrial fibrillation compared to standard treatment and regardless of whether they continued taking anti-arrhythmic medications.
The company’s TAILORED-AF randomized clinical trial, which saw its results published in Nature Medicine, tested the addition of AI-targeted heart ablations to conventional isolations of the pulmonary vein among 370 patients with persistent afib.
Among those who received both types of ablations in a single procedure, 88% of patients saw zero afib symptoms within one year, compared to 70% of those who underwent pulmonary vein isolation alone—pushing the study to meet its primary endpoint.
And, though adding extra ablations doubled the average procedure time, in what’s also known as PVI-plus, safety measures did not significantly differ between the study’s two groups, according to the Marseille, France-based company.
“Previously, there has not been a replicable, effective treatment strategy for patients with persistent atrial fibrillation. Volta’s AI solution finally offers a solution for this large and underserved patient population,” Volta co-founder and CEO Théophile Mohr Durdez said in a statement.
“The TAILORED-AF trial highlights AI’s ability to help physicians treat cardiovascular disease and improve patient outcomes. In fact, this is the first large-scale international [randomized controlled trial] in interventional cardiology demonstrating superior efficacy through the use of AI,” Mohr Durdez said.
Volta’s AF-Xplorer software reads electrogram data from commercially available cardiac mapping systems to detect regions in the heart muscle displaying spatiotemporal dispersion—where pulses may not fully align as electricity surges across the tissue with each heartbeat—centered in clusters that are thought to be drivers of afib.
According to the study’s researchers, PVI-plus methods, including personalized approaches, have previously failed to outperform pulmonary vein isolation alone—a task especially complicated by the need to show consistency and reproducibility across multiple physicians and centers.
Volta’s AF-Xplorer software has received a CE mark approval in Europe and an FDA clearance. In July 2024, the company inked a joint development agreement with GE HealthCare to integrate AF-Xplorer with the medtech’s Prucka 3 and CardioLab EP recording platforms.