- Novel, FDA-cleared and CE-certified medical device is designed to help cardiologists identify cardiac abnormalities in patients undergoing ablation treatment for persistent, drug-resistant atrial fibrillation (AF), a common heart condition.
- New York-Presbyterian Queens, Northwell Health’s Lenox Hill Hospital, New York City, and Ascension St. Vincent’s Riverside, Jacksonville, Fla. are the first U.S. medical centers to use Volta’s VX1 product. All three are participating in an international, randomized, controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation. They are actively recruiting patients for the trials.
MARSEILLE, France and PROVIDENCE, R.I., Dec. 21, 2021 (GLOBE NEWSWIRE) — Volta Medical, a pioneering health tech company developing artificial intelligence (AI)-based software solutions to treat cardiac arrythmias, today announced the introduction of its leading-edge product, VX1, at three leading U.S. hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital both in New York City, and Ascension St. Vincent’s Riverside, Jacksonville, Fla., are the first U.S. 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, randomized controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation. VX1 is cleared as a medical device by the U.S. Food and Drug Administration and CE-certified by the European Union.
VX1 is the first commercially available AI software to help clinicians combat high failure rates in the use of ablation for treating persistent, drug-resistant AF. AF, characterized by an irregular and chaotic heartbeat (cardiac arrythmia), can lead to more serious health issues such as heart failure and stroke. During AF ablation, a specialized cardiologist known as an electrophysiologist inserts catheters through the blood vessels into the heart to burn or freeze that tissue that is causing abnormal electrical signals in the upper chamber, or atrium. The procedure creates scarring that restores a normal heartbeat.
The VX1 system analyzes electrical signals measured during the procedure and identifies abnormalities in real-time. VX1 is versatile and can be installed in most operating rooms and is compatible with the main multipolar catheters and mapping systems.
“We are excited by the potential this approach has to help our patients who are living with persistent, drug-resistant AF,” says Seth Goldbarg, MD, Director of Cardiac Electrophysiology at New York-Presbyterian Queens and assistant professor of clinical medicine at Weill Cornell Medicine. “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.”
Toward that end, Volta Medical has initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches. The international, multi-center 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, MD, Director of Cardiac Electrophysiology at Lenox Hill Hospital, part of Northwell Health. “We’re 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’re pleased to be offering the VX1 system as a promising new treatment strategy for their ablation procedures,” said Saumil R. Oza, MD, a cardiologist with Ascension St. Vincent’s Riverside in Jacksonville, Fla. “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.”
Dr. Seth Goldbarg receives compensation in his role on the scientific advisory board for Volta Medical and the steering committee for the Tailored AF Trial. Dr. Goldbarg also owns shares in Volta Medical.
About Atrial Fibrillation (AF)
An estimated 6.1 million people in the United States have AF with projections to reach nearly 12.1 million in 2030.4,5 Worldwide, it affects more than 33 million people.1 Symptoms include palpitations, lightheadedness and shortness of breath. In some patients, AF can lead to heart failure.1 AF is not only an extremely costly public health issue but also a major risk factor for stroke, posing a 4-to-5 times greater risk than for the general population.6 AF is commonly treated with medication that regulates or slows the heart rate.2 For patients who cannot tolerate or are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care.2 Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heartbeat. However, the efficacy of this approach depends largely on the experience and intuition of the electrophysiologist. With 50% of persistent AF patients requiring repeat treatments,7 the need for more precise therapies is significant.
About the TAILORED-AF trial
TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy 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.
For more information about participating in the TAILORED-AF trial, contact Dan Guerrero daniel.guerrero@volta-medical.com.
About Volta Medical
Volta Medical is a health tech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta’s overarching goal is to significantly improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices based on large databases of procedural data with the highest standards of data protection. Founded by three physicians and a data scientist in 2016 in Marseille, France, Volta’s first product, VX1, assists cardiologists in the real-time identification of specific abnormal electrograms, known as dispersed electrograms. For more information, visit the company’s website at www.volta-medical.com.
Media Contacts United States
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References
1https://kompetenznetz-vorhofflimmern.de/en [last accessed Aug 9, 2021]
3Chugh SS et al. Global Burden of Atrial Fibrillation in Developed and Developing Nations. Global Heart. 2014;9(1):113–9. DOI: https://doi.org/10.1016/j.gheart.2014.01.004
4January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014; 64:2246–2280. DOI: https://www.ahajournals.org/doi/10.1161/cir.0000000000000040
5Colilla 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
6The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC). 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal (2020) 42, 373498. DOI : https://doi.org/10.1093/eurheartj/ehaa612
7Tutuianu C. et al. Very Long-Term Results Of Atrial Fibrillation Ablation Confirm That This Therapy Is Really Effective. J Atr Fibrillation. 2015 Aug-Sep; 8(2): 1226. DOI: https://doi.org/10.4022/jafib.1226
