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

December 2, 2025 updated by: Volta Medical
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Cardiac Arrhythmia Research LLC
        • Contact:
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, MD
    • New York
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients indicated for ablation for atrial fibrillation

Description

Inclusion Criteria:

  1. 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
  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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volta Medical

Collaborators

Heart Rhythm Clinical and Research Solutions, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIPL-01-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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