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

Recruiting now

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06056271

Run by

Volta Medical

People needed

400

Starts

2024-03-19

Expected to finish

2027-12-01

Last updated by the study team

2025-12-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 21 years of age or older who is:
• indicated for AF ablation or
• Who has received an AF-ablation with the past 24 months where VX1 was used or
• Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
• Patients must be able and willing to provide written informed consent to participate in the clinical trial

You may not qualify if…

• Patients not indicated or were not indicated for catheter ablation according to current guidelines
• Patients with AF secondary to an obvious reversible cause
• Patients who are or may potentially be pregnant
• Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug

Where it is running

• Endeavor Health — Evanston, Illinois, United States (enrolling)
• Kansas City Cardiac Arrhythmia Research LLC — Overland Park, Kansas, United States (enrolling)
• Northwell Health — New York, New York, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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