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OpenTrials
Recruiting

NCT Number: NCT06056271

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

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.

Recruiting

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endeavor Health, Evanston, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AF Ablation

Device

Percutaneous, catheter-based ablation of atrial fibrillation

Primary outcomes

  1. Primary Clinical Efficacy Outcome

    Time frame: 12 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Guerrero

CONTACT

[email protected]

612-227-1483

Sponsors and collaborators

Lead sponsor

Volta Medical

Industry

Collaborators

  • Heart Rhythm Clinical and Research Solutions, LLC

Registry information

Acronym: COMPANION AI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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