Volta Medical’s AI Based Solution for Patients in Atrial Fibrillation Achieves Robust Validation in First Peer-Reviewed Publication

Volta Medical, a pioneering health tech company developing artificial intelligence (AI) software solutions to assist electrophysiologists to treat cardiac arrhythmias, announced that the Journal of Cardiovascular Electrophysiology (JCE) has published peer-reviewed results from the Company’s successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution to assist operators in the real-time identification of specific abnormal electrograms (EGM) during atrial fibrillation (AF) procedures.

The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram (EGM) analysis and assists operators in the real-time identification of specific abnormal EGMs, known as dispersed EGMs, during ablation procedures in a persistent AF population. Results demonstrated that VX1 allowed for the building of standardized “Volta VX1 maps”, used as a reference for operators to conduct EGM-guided ablation. The standardization of the detection of abnormal EGMs facilitated a robust patient-to-patient and center-to-center uniformity in EGM-based ablation. No major differences between operator’s visual analysis and VX1 EGM maps were recorded, and there were no statistically significant differences between outcomes across the 8 study centers and 17 operators. Furthermore, after a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively. Also, notably there was acute AF termination of 88% for subjects in all centers.

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“Catheter ablation is well-established as an important treatment for AF and is by far the most common cardiac ablation procedure performed worldwide. Due to the complexity of persistent AF, however, there is no uniform standard of care resulting in heterogenous approaches that yield mixed and often disappointing results associated with high recurrence rates,” said Jean-Paul Albenque, MD, Cardiac Electrophysiologist at the Clinique Pasteur, Toulouse, France, and co-author of the study. “Strategies using EGM assessment to guide ablation visually, rely heavily on the individual experience of the treating electrophysiologist to identify relevant areas making outcomes highly operator-dependent.”

With VX1, Volta has developed the first commercially available companion AI decision support software to assist operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial abnormal EGMs during atrial fibrillation or atrial tachycardia. The cutting-edge software solution uses machine learning including deep learning algorithms to detect abnormal signals and thus highlights potential regions of interest during AF ablation procedures. The system works in real time and identifies specific abnormal EGMs, known as dispersed EGMs.

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Théophile Mohr Durdez, CEO and Co-Founder of Volta Medical, added: “The publication of these peer-reviewed trial results provides further validation of our approach – to leverage AI with cutting-edge software solutions and assist operators during cardiac ablation procedures. Over 1000 procedures have so far been supported in the EU and US by VX1 and based on clinician’s feedback and clinical results, we are confident that this approach will ultimately contribute to make ablation outcomes significantly more reliable.”

Based on these encouraging results, Volta Medical has initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach. The aim of the study is to confirm the clinical significance of Volta Medical’s technology and lay the ground for establishing VX1 as a new standard of care for persistent AF ablation.

“The results of the Ev-AIFib trial show that Volta’s AI enhanced VX1 software is finally able to provide reliability and reproducibility in an EGM based approach – the holy grail of EGM based ablation approaches. The technology has shown a high potential to assist in treating the complex persistent AF patients,” said Prof. Dr. Isabel Deisenhofer, MD, head of electrophysiology at German Heart Centre Munich, and principial investigator of the international, multicenter TAILORED-AF trial. She continues: “In my experience, VX1 has been an extremely helpful tool, and I look forward to further explore and confirm the technology’s potential in the ongoing TAILORED-AF trial.”

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