Volta Medical's Transatlantic Trial: AI-Assisted Ablation vs. Conventional Treatment for Atrial Fibrillation
21 May 2024
Volta Medical, a leader in health technology, recently shared promising findings from the TAILORED-AF (Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation) trial at the Heart Rhythm 2024 Late Breaking Clinical Trials and Science program.
Led by Professor Isabel Deisenhofer of the Munich Heart Center, the trial, registered as clinicaltrials.gov NCT04702451, evaluated Volta's AI decision support system alongside Pulmonary Vein Isolation (PVI) for patients with persistent or long-standing persistent atrial fibrillation (AF). The aim was to achieve greater freedom from documented AF with or without anti-arrhythmic drugs at the 12-month mark.
The trial enrolled adults with symptomatic AF from Europe and the United States who were eligible for their first ablation procedure. Among them, 187 patients underwent tailored cardiac ablation with Volta's AI technology alongside PVI (Tailored cohort), while 183 patients received the standard PVI-only treatment (Anatomical cohort).
The study involved 51 electrophysiologists across 26 centers in five countries and followed participants for a year. Results demonstrated the superiority of the Tailored cohort, with 88% experiencing AF freedom compared to 70% in the Anatomical cohort. Additionally, 66% of patients in the Tailored arm saw acute AF termination, compared to only 15% in the Anatomical arm.
The trial examined predefined secondary endpoints and a subgroup of patients with sustained persistent AF lasting six months or longer before enrollment.
Notably, the Tailored cohort, after an average of 1.2 procedures, exhibited a higher rate of freedom from any arrhythmia, particularly among those with sustained persistent AF of six months or more.
This groundbreaking trial represents the first large-scale transatlantic randomized controlled study demonstrating the benefits of an augmented ablation strategy beyond PVI alone for persistent AF patients, addressing the longstanding challenge of inconsistent effectiveness in previous studies.
Source: volta-medical.eu
