Marseille (France), MAY 20, 2024

Volta Medical presents results from the first transatlantic randomized controlled trial comparing AI-assisted ablation procedure with the 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.

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.

About Atrial Fibrillation

The American Heart Association (AHA) defines atrial fibrillation (AF) as an, irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.2 Approximately 33 million patients worldwide are living with AF.3,4 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition.

About the TAILORED-AF Trial

TAILORED-AF is an international, multicenter, randomized controlled trial designed to determine if a tailored AI software-guided ablation procedure targeting areas of spatio-temporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12- month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024.

About Volta Medical

Volta Medical is a health-tech company developing artificial intelligence software solutions created to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 and based in Marseille, France, the company’s mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. 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 during AF and atrial tachycardia procedures.  The AF-Xplorer™ has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities.  The company has obtained U.S. FDA 510(k) clearance* and European CE Mark approval for its innovative products.

* The clinical significance of utilizing the Volta AF-Xplorer™ software for catheter ablation of atrial arrhythmias has not been reviewed by the FDA.

U.S. Media Contact

Glenn Silver
Finn Partners
glenn.silver(at)finnpartners.com

Volta Medical Contact

Jeff Martin, VP of Global Marketing
Volta Medical
jeffrey.martin(at)volta-medical.com

References
1. Verma, Atul, et al. "Approaches to catheter ablation for persistent atrial fibrillation." New England Journal of Medicine 372.19 (2015): 1812-1822.
2. https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
3. 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
4. https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]