Post-Market Study of AI-Powered Afib Identification Underway

Vektor Medical has begun a clinical study to evaluate the use of artificial intelligence (AI)-driven mapping to identify and ablate non-pulmonary vein electrical drivers implicated in persistent and recurrent atrial fibrillation (AF).

IMPRoVED AF (artificial Intelligence Mapping and ablation of non-PulmonaRy Vein Electrical Drivers of AF) is a prospective, randomized, controlled, multi-center study that will rigorously compare clinical outcomes in patients undergoing pulmonary vein isolation (PVI) alone versus PVI and additional driver ablation guided by Vektor’s proprietary vMap technology. vMap is billed as the only U.S. Food and Drug Administration (FDA)-cleared non-invasive AI-powered arrhythmia analysis technology for improving, enhancing, and accelerating ablation procedures, using data from a standard 12-lead ECG.

“Persistent and recurrent AF remains incredibly challenging, profoundly affecting patient quality of life and burdening our healthcare systems,” said Dr. Gery Tomassoni, principal study investigator and cardiac electrophysiologist at Baptist Health Lexington. “The IMPRoVED AF study is positioned to address this challenge. By leveraging AI-driven technology, we aim to significantly enhance ablation accuracy and effectiveness, potentially redefining the standard for managing persistent AF.”

Managed by clinical research organization Veranex, the study will enroll up to 384 patients with persistent (not longstanding) and recurrent AF at 15 U.S. and European electrophysiology centers. The study is specifically designed to demonstrate the comparative clinical benefit of using AI-driven mapping to identify and ablate non-pulmonary vein electrical hotspots in accordance with standard-of-care ablation practices.

The primary endpoint of the study is freedom from AF on or off antiarrhythmic drugs at 12 months.

Additional secondary endpoints include:

• freedom from AF and atrial tachycardia on and off antiarrhythmic drugs at 12 months
• total procedure time
• total vMap mapping time
• AF burden as a proportion of time before vs. after ablation
• proportion of subjects with AF terminated spontaneously upon and after the first ablation, and total fluoroscopy dose.

Interim results are expected by HRS 2026; comprehensive results are expected at HRS 2027.

“EPs can’t ablate what they can’t identify. That’s exactly why vMap was created—to empower EPs with actionable insights previously inaccessible from a standard ECG,” Vektor Medical CEO Rob Krummen stated. “The IMPRoVED AF trial represents a landmark moment for Vektor, validating vMap’s clinical efficacy and demonstrating our ability to dramatically improve outcomes and redefine arrhythmia care. Re-do procedures have unfortunately become the norm, underscoring the critical need for technologies that provide additional insight on arrhythmia sources.”

In parallel with the IMPRoVED AF study, Vektor has also initiated the VITAL-EP registry to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures. The registry, managed by clinical research organization Heart Rhythm Clinical and Research Solutions, is targeting a 110-patient enrollment across four sites. The registry will evaluate multiple procedural-related endpoints, including AF termination or AF non-inducibility in AF ablation cases and procedure efficiency, including procedure duration and fluoroscopy use.

vMap is a non-invasive AI-based solution for mapping arrhythmias using just a 12-lead ECG. vMap localizes arrhythmia sources for focal and fibrillation-type arrhythmias, including atrial fibrillation. By unlocking actionable insights contained within a standard 12-lead ECG, vMap enables physicians to rapidly and accurately locate arrhythmia source locations. Backed by extensive clinical evidence, vMap not only improves patient outcomes but also reduces procedure time, optimizing workflow across the entire arrhythmia care pathway.

Headquartered in San Diego, Vektor Medical strives to improve arrhythmia care. Through its AI-powered, non-invasive arrhythmia analysis technology, vMap, the company aims to improve cardiac ablation outcomes, optimize workflows, and increase procedural efficiency.