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 Study. The Proof-of-Concept-Study investigated the use of Volta’s lead product 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 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.
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 AF 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.
About Ev-AIFib Trial
The EV-AIFib trial, a prospective, multicenter, non-randomized, study was designed to determine the feasibility and relevance of constructing standardized dispersion maps, so called ‘Volta VX1 maps’, to be used as a reference to operators conducting EGM-guided ablation of patients in persistent AF, as well as the use of VX1 for center-to-center standardization of dispersion mapping. In the trial physicians were provided with VX1 adjudications in real time and used their discretion to ablate where it was the most clinically relevant. Carried out in 8 different centers with 17 participating operators, the study compared the acute and long-term outcomes of 85 patients after ablation in regions exhibiting dispersion between a primary and satellite centers. At the primary center, operators were the most experienced at dispersion-based ablation, while satellite centers corresponded to hospitals where physicians had little experience at performing dispersion-based ablation. The results were also compared to a control group in which dispersion-guided ablation was performed visually by trained operators. The article titled “Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation” is available here.
About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a health tech company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures. Volta’s overarching goal is to drastically improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data with the highest standards of data protection. Its first product, VX1, a digital AI companion device and algorithm assists cardiologists for the real-time identification of specific abnormal EGMs, known as dispersed EGMs. For more information, visit the company’s website at www.volta-medical.com.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor with two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in fast growing, innovative companies active in (bio)pharmaceuticals, healthtech and medtech that are based in Europe and North America. For more information, please visit: www.gildehealthcare.com.
