Feb. 14, 2025 — Volta Medical, a health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, has published the 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.
In particular, 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. Despite advances in catheter ablation technology, persistent AF remains one of the most challenging subtypes of atrial fibrillation to treat, affecting over 70% of all patients with atrial fibrillation globally.i
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.”
Summary and Results
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 centers in 5 countries across the US and the EU participated. For access to the full publication visit https://www.nature.com/articles/s41591-025-03517-w.
The trial met the primary endpoint by demonstrating superior results 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 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.
“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,” said Seth Goldbarg, MD, FACC, FHRS, Cardiologist, NewYork-Presbyterian, Queens. “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.”
References
- David DeLurgio, Jaswinder Gill, Syed Ahsan, Riyaz Kaba, Kristen M Plasseraud, Michael E Halkos, Hybrid Convergent Procedure for the Treatment of Persistent and Long-standing Persistent Atrial Fibrillation, Arrhythmia & Electrophysiology Review 2021;10(3):198–204. https://doi.org/10.15420/aer.2021.24
- https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
- Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/j.amjcard.2013.05.063
- https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]
- https://www.mddionline.com/cardiovascular/medtronic-makes-a-double-play-for-atrial-fibrillation
March 12, 2025 
