Study Comparing AI ECG Mapping Plus Pulmonary Vein Isolation to Pulmonary Vein Isolation Alone for Treating Atrial Fibrillation in Adults

What this Trial Is About

Researchers are evaluating the use of the Vektor Computational ECG Mapping System vMap4 combined with pulmonary vein isolation PVI compared to PVI alone for treating adults with persistent or recurrent atrial fibrillation AF. This post-market, prospective, multi-center randomized clinical study aims to compare clinical outcomes in patients undergoing ablation procedures for AF using either standard care or the vMap4 system, which is FDA-cleared and commercially available. Participants will be randomly assigned to one of two groups one group will receive PVI alone, while the other will undergo ablation guided by the vMap4 system in addition to PVI. Both groups follow standard ablation procedures, with the vMap4 system used to identify and map electrical drivers of AF to plan the ablation. The study evaluates these two approaches to understand differences in treatment outcomes. During the study, participants will be monitored for one year after their procedure to assess freedom from atrial fibrillation. Researchers will collect data on procedure time, mapping duration, AF burden, spontaneous AF termination, and fluoroscopy dose. Participants will follow up with study visits and evaluations in line with the protocol to measure these outcomes and monitor safety throughout the 12-month period.

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study