Clinical Trial

Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation

Study acronym: COMPANION AI
Recruiting
View on ClinicalTrials.gov →
Summary
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-09-20; most recent amendment 2025-12-02.
Status change: Not Yet Recruiting → Recruiting 2024-04-22
Trial Details
NCT Number NCT06056271
Lead Sponsor Volta Medical
Collaborators: Heart Rhythm Clinical and Research Solutions, LLC
Conditions Atrial Fibrillation
Enrollment 400 participants
Start Date 2024-03-19
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-10