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.

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.

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. A total of 187 patients underwent a tailored cardiac ablation guided by Volta’s AI technology 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 participated. The trial met the primary endpoint by demonstrating superiority in patients assigned to the Tailored cohort compared to the Anatomical cohort. 88% of patients in the Tailored cohort experienced freedom from AF 12 months post procedure with or without anti-arrhythmic drugs compared to 70% in the anatomical cohort. Additionally, 66% of patients in the Tailored arm experienced termination of acute AF, compared to 15% of patients in the Anatomical arm.  The trial also examined several pre-specified secondary endpoints and a pre-specified subgroup of patients with sustained persistent AF lasting 6 months or longer prior to enrollment. Patients in the Tailored cohort experienced a higher rate of freedom from any arrhythmia after 1.2 procedures, particularly for patients with sustained persistent AF ≥ 6 months.