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, health tech company Volta Medical has announced.
The landmark TAILORED-AF clinical trial 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.
Despite advances in catheter ablation technology, persistent AF remains one of the most challenging subtypes of atrial fibrillation to treat, affecting over 70 per cent of all patients with atrial fibrillation globally.
The TAILORED-AF clinical trial is the first large-scale transatlantic randomized controlled trial (RCT) of ablation in a persistent AF population to show the benefit of going beyond conventional 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.
Théophile Mohr-Durdez, CEO and co-founder of Volta Medical.
Mohr-Durdez said: “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.
“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.
A total of 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 centres in 5 countries across the US and the EU participated.
The trial met the primary endpoint by demonstrating superior results in patients assigned to the Tailored cohort compared to the Anatomical cohort.
Seth Goldbarg, MD, FACC, FHRS, Cardiologist, NewYork-Presbyterian, Queens, said: “Atrial fibrillation, when left untreated, doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke.
“However, advancements in AI are transforming this landscape.
“This trial featuring AI-guided assessment of AF represents a true milestone for improvement of outcomes for this underserved and difficult to treat patient community.”
