SAN DIEGO — Vektor Medical has announced the launch of a new clinical trial aimed at assessing whether its AI-powered arrhythmia mapping technology can enhance treatment outcomes for patients with persistent and recurrent atrial fibrillation (AF). The study, called IMPRoVED AF, will evaluate the benefits of using the company’s vMap technology to identify and ablate non-pulmonary vein electrical drivers that contribute to AF, supplementing standard pulmonary vein isolation (PVI) procedures.
Persistent and recurrent AF remain challenging to treat, with many patients requiring repeat ablation procedures. Vektor’s vMap system, the only FDA-cleared non-invasive AI-powered arrhythmia analysis platform, uses standard 12-lead ECG data to pinpoint arrhythmia sources beyond the pulmonary veins. The company believes that by targeting these additional electrical drivers, clinicians can achieve more durable treatment outcomes.
The IMPRoVED AF trial is a prospective, randomized, controlled, multi-center study designed to compare outcomes between two groups of patients undergoing AF ablation. One group will receive PVI alone, while the other will undergo PVI plus additional ablation guided by vMap technology. The study, managed by clinical research organization Veranex, will enroll up to 384 patients with persistent and recurrent AF across 15 electrophysiology centers in the United States and Europe.
“The IMPRoVED AF study is positioned to tackle one of the biggest challenges in electrophysiology,” said Dr. Gery Tomassoni, the study’s principal investigator and a cardiac electrophysiologist at Baptist Health Lexington. “By incorporating AI-driven mapping, we hope to improve the precision and effectiveness of ablation procedures, which could ultimately redefine how persistent AF is treated.”
The trial’s primary endpoint is freedom from AF at 12 months, with or without antiarrhythmic drugs. Secondary endpoints include rates of atrial tachycardia, total procedure and mapping times, AF burden before and after ablation, and fluoroscopy exposure. Interim results from the study are expected in 2026, with full results anticipated by 2027.
Rob Krummen, CEO of Vektor Medical, described the trial as a pivotal moment for the company. “Electrophysiologists can’t ablate what they can’t identify. vMap was designed to bridge that gap, offering actionable insights that weren’t accessible through standard ECG analysis. The IMPRoVED AF trial will validate vMap’s clinical utility and show how it can dramatically improve ablation outcomes,” Krummen said. He also highlighted the growing need for better solutions as repeat ablation procedures have become common due to incomplete treatment of AF sources.
Alongside the IMPRoVED AF trial, Vektor Medical has initiated the VITAL-EP registry to collect real-world evidence on the clinical performance and safety of vMap-guided ablation procedures. Managed by Heart Rhythm Clinical and Research Solutions, the registry will enroll at least 110 patients across four clinical sites. It will assess outcomes such as AF termination, non-inducibility of AF during procedures, and overall procedural efficiency, including time and fluoroscopy use.
Together, these initiatives reflect Vektor Medical’s focus on advancing data-driven solutions that enhance adoption of electrophysiology tools and improve ablation outcomes for patients with complex arrhythmias.
