RecruitingNCT06056271

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


Sponsor

Volta Medical

Enrollment

400 participants

Start Date

Mar 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how well an AI-assisted companion technology (VX1) helps doctors during catheter ablation procedures for atrial fibrillation (AF) — a common irregular heart rhythm — and whether it improves patient outcomes in real-world settings. **You may be eligible if...** - You are 21 years or older - You are indicated for or have already received catheter ablation for atrial fibrillation within the past 24 months using the VX1 system - You are able and willing to provide written informed consent **You may NOT be eligible if...** - You are not a candidate for catheter ablation per current guidelines - Your atrial fibrillation is caused by a reversible condition (e.g., thyroid disease, surgery) - You are or may be pregnant - You are enrolled in another investigational device or drug study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAF Ablation

Percutaneous, catheter-based ablation of atrial fibrillation


Locations(4)

Endeavor Health

Evanston, Illinois, United States

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas, United States

Northwell Health

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06056271


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