Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologist physicians in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced the completion of patient enrollment in the randomized controlled clinical trial, TAILORED-AF, evaluating VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach. The company’s lead product,VX1, is the first commercially available AI decision-support software to help guide physicians with identification and real-time annotation of unique abnormalities (so called“dispersed electrograms“) on 3D anatomical and electrical maps of the heart. This technology ultimately may lead to optimized catheter-ablationprocedures for complex arrhythmias, including persistent AF.
“Atrial fibrillation isthe most common heart rhythm disturbance in adults and the need for more precise therapies is significant,” said Professor Isabel Deisenhofer, MD, ofGerman Heart Center in Munich, Germany and primary investigator for the trial.“While catheter ablation is well-established as an important treatment for AF,a more consistent standard of care is needed for its more progressed diseasestate, known as persistent AF. VX-1 has the potential to meet that need byassisting electrophysiologists in delivering successful outcomes with eachpatient ablation.” The TAILORED-AF clinical trial is aninternational, multicenter, randomized controlled study designed to confirm the clinical significanceof VX1 and lay the groundwork for establishing VX1 as a new standard of carefor persistent AF ablation. The primary endpoint is freedom from documented AFepisodes lasting longer than 30 seconds, with or without anti-arrhythmic drugs(AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/oratrial tachycardia (AT) episodes after a 12-month period, following one or moreprocedures, as well as safety.
“We are committed to helping physicians use EGM-assessment software to guide ablation and providing another clinical tool to support the best possible outcomes for patients,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “We are excited to complete patient enrollment in this 26-site controlled trial and continue studying our VX1 platform, and look forward to reporting the results in 2024 to provide electrophysiologists more essential, life-changing care options to patients.”
About the TAILORED-AF Trial
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 atrial fibrillation doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition.
About Volta Medical
Volta Medical is a health technology company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. 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 US and is pending CE-mark for use in the EU.
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