Volta Medical Announces Clinical Trial Results of AI-Guided Cardiac Ablation Procedure

Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, announced the publication of the landmark TAILORED-AF clinical trial in Nature Medicine, which demonstrated that an AI-guided procedure for persistent atrial fibrillation (AF) in combination with conventional pulmonary vein isolation (PVI) treatment, resulted in better outcomes than PVI alone. 

The TAILORED-AF clinical trial is the first large-scale transatlantic randomized controlled trial (RCT) of ablation in a persistent atrial fibrillation (AF) population to show the benefit of going beyond conventional pulmonary vein isolation (PVI)-only extra-pulmonary vein procedure. Previous studies looking at ablation strategies for persistent AF patients have not demonstrated superior efficacy to PVI alone. 

The Volta AF-Xplorer is a digital AI companion designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal dispersed EGMs; this technology was used in the TAILORED-AF trial.

“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,” said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. “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 RCT in interventional cardiology demonstrating superior efficacy through the use of AI.”

In the clinical trial, adults with symptomatic persistent or long-standing persistent AF who were candidates for a first-time ablation were enrolled in Europe and the United States. 187 patients underwent a tailored cardiac ablation guided by Volta’s AI in addition to PVI (Tailored cohort), and 183 patients received the conventional treatment of PVI-only (Anatomical cohort) and all were followed up for 12 months. A total of 51 electrophysiologists at 26 centers in 5 countries across the US and the EU participated.

The study showed superiority in the percentage of patients that achieved freedom from atrial fibrillation (AF) with or without anti-arrhythmic drugs at 12 months after a tailored cardiac ablation guided by AI in combination with PVI when compared to PVI alone. 

Key Results

• 88% of patients in the Tailored cohort experienced freedom from AF 12 months after one procedure with or without anti-arrhythmic drugs compared to 70% in the Anatomical cohort (log rank p < 0.0001).
• In the Tailored cohort, patients experienced a higher rate of freedom from any arrhythmia after 1.2 procedures than in the Anatomical cohort (79% vs. 71%, log rank p < 0.01). Recurrences in the Tailored cohort were regarded as a “simplification” of AF which are generally easier to ablate and can be seen as a step towards stable sinus rhythm.
• The trial also examined several pre-specified secondary endpoints and a pre-specified subgroup analysis of patients with sustained persistent AF lasting 6 months or longer prior to enrollment. These patients represent a more advanced AF disease progression. Patients in the Tailored cohort experienced a significantly higher rate of freedom from any arrhythmia after one single procedure than in the Anatomical cohort (62% vs. 48%, log rank p = 0.04).
• The safety endpoint did not differ between the groups, although the procedure and ablation time were twice as long in the Tailored arm, consistent with treatment time for other PVI+ methods.