NCT06935591

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 423 (estimated)
• Sponsor: Vektor Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).

Detailed description

This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation \[vMap®+PVI\]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	Pulmonary Vein Isolation	Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.
DEVICE	vMap® + Pulmonary Vein Isolation	Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.

Timeline

• Start date: 2025-06-27
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-04-20
• Last updated: 2026-03-16

Locations

13 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study