Volta Medical, a Marseille-based medtech specializing in AI solutions applied to cardiology, recently published the results of its TAILORED-AF clinical trial in the prestigious journal Nature Medicine. This study demonstrates the effectiveness of AI in improving the treatment of persistent atrial fibrillation (AF), marking a significant advancement in interventional medicine.
Atrial fibrillation affects approximately 33 million patients worldwide, including more than 600,000 in France. This cardiac arrhythmia can lead to blood clots, strokes, heart failure, and other complications.
To improve the management of this condition and thus the lives of these patients, Théophile Mohr-Durdez, a data scientist, and three rhythmologist cardiologists, Julien Seitz, Jérôme Kalifa, and Clément Bars, founded Volta Medical in 2016.
A 2024 French Tech 120 laureate, the medtech develops cutting-edge medical devices trained on large databases. Its flagship product, Volta AF-Xplorer™, is an AI-based digital assistant designed to help cardiologists identify specific abnormal electrograms (EGM) in real time, known as spatio-temporal dispersed EGMs. This versatile device can be used with the most common mapping systems and electrophysiology suites, as well as the most prevalent ablation modalities. It was this technology that was used during the TAILORED-AF trial.
Demonstrating the Effectiveness of AI
The TAILORED-AF clinical trial (Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial) was designed to determine whether an ablation procedure guided by Volta AF-Xplorer in combination with the conventional pulmonary vein isolation (PVI) technique is superior to PVI alone for treating persistent AF.
Volta Medical recruited 370 patients in Europe and the United States, candidates for a first-time cardiac ablation: 187 were operated on by cardiologists assisted by AI, while the other 183 underwent the conventional technique.
The results are significant: 88% of patients who underwent the AI-assisted procedure did not experience a recurrence of atrial fibrillation 12 months after the intervention, compared to 70% in the group treated with PVI alone. Furthermore, a subgroup of patients with sustained persistent AF for at least 6 months before inclusion experienced a higher rate of freedom from arrhythmia recurrence after a single procedure.
A Paradigm Shift in Interventional Cardiology
Until now, no standardized approach had significantly improved success rates for cardiac ablations of persistent atrial fibrillation. The TAILORED-AF study thus paves the way for more precise and effective management, which could redefine treatment protocols.
Théophile Mohr-Durdez, CEO and co-founder of Volta Medical, emphasizes:
"Our AI solution allows for better mapping of heart areas to be treated and finally offers an effective treatment to this very large and underserved patient population."