Actively Recruiting

Age: 21Years +
All Genders
NCT06056271

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

Led by Volta Medical · Updated on 2025-12-10

400

Participants Needed

4

Research Sites

193 weeks

Total Duration

On this page

Sponsors

V

Volta Medical

Lead Sponsor

H

Heart Rhythm Clinical and Research Solutions, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 21 years of age or older who are indicated for AF ablation or have received an AF ablation with VX1 in the past 24 months
  • Patients receiving or having received catheter ablation for AF according to current guidelines
  • Patients able and willing to provide written informed consent to participate in the clinical trial
Not Eligible

You will not qualify if you...

  • Patients not indicated for catheter ablation according to current guidelines
  • Patients with atrial fibrillation caused by an obvious reversible condition
  • Patients who are or may be pregnant
  • Patients enrolled in another investigational study evaluating a non-VX1 device, biologic, or drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Endeavor Health

Evanston, Illinois, United States, 60201

Actively Recruiting

2

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States, 66211

Actively Recruiting

3

Northwell Health

New York, New York, United States, 10075

Actively Recruiting

4

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

D

Daniel Guerrero

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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