Vektor Medical Announces Post-Market Study Evaluating Benefit of AI-Powered Analysis to Identify and Ablate Non-Pulmonary Vein AF Targets

Vektor Medical, a leader in non-invasive, AI-powered arrhythmia analysis technology, today announced the initiation of the IMPRoVED AF clinical study designed to evaluate the benefit of utilizing 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 clinical trial 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 the only FDA-cleared non-invasive AI-powered arrhythmia analysis technology designed to improve, enhance, and accelerate ablation procedures, utilizing 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 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.”

The study, managed by clinical research organization Veranex, will enroll up to 384 patients with persistent (not longstanding) and recurrent AF at 15 electrophysiology centers across the United States and Europe. The study’s design specifically aims to demonstrate the comparative clinical benefit of utilizing 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 versus after ablation
• proportion of subjects with AF terminated spontaneously upon and after the first ablation, and total fluoroscopy dose.

Interim results are anticipated 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,” said Rob Krummen, CEO of Vektor Medical. “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, aims to enroll at least 110 patients 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 the only FDA-cleared, non-invasive AI-based solution for mapping arrhythmias, utilizing 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.