EQS-News

Volta Medical presents results from first transatlantic randomized controlled trial comparing AI-assisted ablation procedure with conventional treatment for persistent atrial fibrillation patients

EQS-News: Volta Medical SAS / Key word(s): Study results Volta Medical presents results from first transatlantic randomized controlled trial comparing AI-assisted ablation procedure with conventional treatment for persistent atrial fibrillation patients 20.05.2024 / 14:00 CET/CEST The issuer is solely responsible for the content of this announcement. Volta Medical presents results from first transatlantic randomized controlled trial comparing AI-assisted ablation procedure with conventional treatment for persistent atrial fibrillation patients

• TAILORED-AF trial findings demonstrated superiority in freedom from atrial fibrillation (AF) with or without anti-arrhythmic drugs at 12 months from a tailored cardiac ablation guided by artificial intelligence (AI) when compared to pulmonary vein isolation (PVI) alone. 

Marseille (France), May 20, 2024 – Volta Medical, a pioneering health-tech company developing AI based solutions to assist electrophysiologists, announced positive results from the transatlantic, multicenter, randomized, controlled, superiority trial titled Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (TAILORED-AF) at Heart Rhythm 2024 Late Breaking Clinical Trials and Science program. Results from this FDA IDE trial (clinicaltrials.gov NCT04702451) presented by the principal investigator Professor Isabel Deisenhofer (Munich Heart Center, Munich Germany), demonstrated that utilization of Volta’s AI decision support system in addition to PVI was superior to a PVI-only procedure in persistent or long-standing persistent AF patients in attaining patient freedom from documented AF with or without anti-arrhythmic drugs at 12 months. Volta’s AI decision support system was used to enable a tailored cardiac ablation procedure for patients in the Tailored cohort. The AI solution is designed to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as spatio-temporal dispersed EGMs. This is the first large-scale transatlantic randomized controlled trial of ablation in a persistent AF population to show the benefit of an extra-pulmonary vein procedure vs. conventional treatment of PVI-only. Previous landmark studies looking at ablation strategies for persistent AF patients have demonstrated a lack of a consistent ablation strategy that is effective for patients, with a clinical success rate in past trials of 50%¹.