Volta Medical has announced the introduction of VX1 artificial intelligence (AI) software at three US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital both in New York, and Ascension St. Vincent’s Riverside, Jacksonville, have been named as the first US hospitals to implement VX1, which is designed to improve outcomes for patients undergoing atrial fibrillation (AF) ablation procedures.
All three hospitals also are recruiting AF ablation patients to participate in an international, randomised controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation. VX1 is cleared as a medical device by the US Food and Drug Administration (FDA) and CE-marked by the European Union.
Volta describes VX1 as the first commercially available AI software to help clinicians combat high failure rates in the use of ablation for treating persistent, drug-resistant AF.
The VX1 system analyses electrical signals measured during the procedure and identifies abnormalities in real-time.
“We are excited by the potential this approach has to help our patients who are living with persistent, drug-resistant AF,” says Seth Goldbarg, director of Cardiac Electrophysiology at New York-Presbyterian Queens and assistant professor of clinical medicine at Weill Cornell Medicine (New York, USA). “The VX1 system may help us tailor our procedures for each patient by more precisely pinpointing optimal ablation locations in real time.”
“To date, electrophysiologists have relied on their own experience and on simple analysis tools to make decisions about ablation locations as opposed to using robust measurable electrical abnormalities,” said Théophile Mohr Durdez, CEO and co-founder of Volta Medical. “To date, we have supported approximately 500 procedures with our AI-based analysis and the feedback has been excellent. We are very confident that this approach can help revolutionize the field and prove to significantly improve patient outcomes.”
Volta Medical has initiated the TAILORED-AF trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches. The international, multicentre trial will involve 25 sites and 342 patients and is expected to report results in 2024.
“Treating the large number of patients with severe forms of drug-resistant, persistent AF remains an ongoing challenge for clinicians because current therapeutic strategies cannot offer predictable efficacy,” said Stavros Mountantonakis, director of Cardiac Electrophysiology at Lenox Hill Hospital, part of Northwell Health. “We are finding VX1 to be a valuable tool in our ablation procedures, and we’re hopeful that the TAILORED-AF trial will validate its use as a game-changing innovation in ensuring improved, long-term results for these patients.”
“Our patients with drug-resistant, persistent AF face many ongoing challenges, and we are pleased to be offering the VX1 system as a promising new treatment strategy for their ablation procedures,” said Saumil R Oza, a cardiologist with Ascension St. Vincent’s Riverside, Jacksonville, USA. “Current ablation techniques cannot offer predictable efficacy, which is why the VX1 system holds so much promise. Because it enables us to precisely pinpoint optimal ablation locations for each patient, we are confident that it will lead to better treatment outcomes.”