Trial Begins for Evaluating Repeat Atrial Fibrillation Treatment

Volta Medical has begun its Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART) study to evaluate Volta’s AI ablation solution in recurrent-AF patients who failed previous ablations and are undergoing Volta-supported ablation.
 
“Strategies for ‘redo’ ablation in this population vary widely, leading to multiple approaches with mixed results and high recurrence rates,” said Dr. John Hummel, M.D., director of Electrophysiology at the Ohio State University Wexner Medical Center and the trial’s principal investigator. “With 50% of persistent AF patients requiring repeat treatments, the use of an approach like Volta’s AI ablation solution supports electrophysiologists by identifying areas of interest during these complex procedures.”
 
Volta Medical has launched the first commercially available AI decision-support software that can assist electrophysiologists in real-time during AF catheter-ablation procedures for drug resistant, persistent AF, by identifying and annotating unique abnormalities (dispersed electrograms) on 3D anatomical and electrical heart maps. This AI companion solution ultimately may lead to optimized catheter-ablation procedures for complex arrhythmias, including persistent AF.
 
“Catheter ablation is a well-established treatment for atrial fibrillation; however, there are no uniform techniques for performing these complex procedures, which require physicians to analyze large amounts of data in real time,” Volta Medical Co-Founder/Chief Medical Officer Jerome Kalifa, M.D., Ph.D., stated. “Volta is committed to providing an AI-based solution with the potential to help electrophysiologists deliver successful outcomes, including in these complex ‘redo’ ablation cases. We look forward to reporting results in 2025.”
 
The RESTART clinical trial is an international, multicenter, non-randomized interventional study evaluating outcomes in recurrent-AF patients who failed previous ablations and who are now undergoing Volta AI assisted ablation, to assess if patients will be AF-free, without antiarrhythmic drugs, 12 months after their procedure. Enrollment for the trial is set at 92 patients at 16 U.S. and five European sites.
 
The RESTART trial adds to a clinical evidence roadmap that Volta has committed to demonstrate the effectiveness of dispersion EGM guided ablation and their machine learning AI decision support system. The first clinical trial for Volta’s AI solution was the EV-AIFib trial, a prospective, multicenter, non-randomized, study designed to determine the feasibility and relevance of constructing standardized dispersion maps to be used as a reference to operators conducting EGM-guided ablation. The study demonstrated similar acute and long-term outcomes of 85 patients after ablation in regions exhibiting dispersion between a primary (expert) and satellite (novice) centers.
 
The company recently completed enrollment in TAILORED-AF, a randomized, controlled, international multicenter trial in 374 patients designed to determine if a tailored AI software-guided ablation strategy targeting areas of dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy targeting PVI alone for treating  persistent AF. Results are expected next year.
 
The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.¹ At least 6.1 million Americans and approximately 33 million patients worldwide are living with AF.^2,3 Even though untreated AF doubles the risk of heart-related deaths and is associated with a five-fold increased risk for stroke, many patients are unaware that AF is a serious condition.
 
Volta Medical is a health technology company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes. Founded by three physicians and a data scientist in 2016 in Marseille, Volta’s overarching goal is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The company’s first product, VX1, is a digital AI companion device and algorithm to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as dispersed EGMs. Its second software iteration, Volta AF-Xplorer is now cleared for use in the United States and is pending CE-mark for use in the European Union. 

References
¹ https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
² 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
³ https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]