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Observational Study of AI-Guided AF Ablation

This study is looking at the real-world use of Volta Medical's VX1 or AF-Xplorer systems during an atrial fibrillation (AF) ablation procedure. AF ablation is a treatment for an irregular heartbeat. The study aims to see how well these AI systems work in patients who have AF ablation. You might be able to join if you are 21 or older and are scheduled for an AF ablation, or if you've already had one using VX1 within the last 24 months. The main goal is to observe the clinical outcomes (how well patients do) at 12 and 24 months after the procedure. The study is currently unclear on its recruitment status.

Study design
This is an observational study involving 400 participants across multiple centers in the US. It is a registry, meaning it collects information about patients who are already receiving treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants' clinical outcomes will be observed for 12 and 24 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06056271

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

Recruiting
Not specifiedAges 21+Observational
Volta Medical
~400 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:AF Ablation

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Clinical Efficacy Outcome
Measured over 12 and 24 months

Conditions

Atrial Fibrillation

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NCT06056271

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Endeavor Health

    Evanston, Illinoisstudy coordinator listed

    Recruiting

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansasstudy coordinator listed

    Recruiting

  • Northwell Health

    New York, New Yorkno site contact published

    Recruiting

  • Ohio State University

    Columbus, Ohiono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Daniel Guerrero
[email protected]
612-227-1483
Email the study team

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Eligibility criteria

Inclusion

indicated for AF ablation or
Who has received an AF-ablation with the past 24 months where VX1 was used or 2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines 3. Patients must be able and willing to provide written informed consent to participate in the clinical trial

What this trial measures

  • Primary Clinical Efficacy Outcome12 and 24 months

    Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.