MedTrace Logo

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

NCT06935591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2026-03-16

No results posted yet for this study

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).

Conditions

  • Atrial Fibrillation (AF)

Interventions

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.

Sponsors & Collaborators

  • Veranex Switzerland SA

    collaborator INDUSTRY

  • Veranex

    collaborator UNKNOWN

  • Vektor Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935591 on ClinicalTrials.gov