Observing outcomes of using AI during heart ablation for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data on clinical outcomes for patients undergoing atrial fibrillation (AF) ablation procedures using Volta Medical's VX1 or AF-Explorer systems. It involves multiple centers across the United States and focuses on patients who are either indicated for AF ablation or have undergone the procedure within the last 24 months. The study will track the effectiveness and safety of these AI-assisted mapping systems in real-world clinical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Endeavor Health
  Evanston, Illinois, United States Recruiting
• Kansas City Cardiac Arrhythmia Research LLC
  Overland Park, Kansas, United States Recruiting
• Northwell Health
  New York, New York, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Daniel Guerrero
• Email: daniel.guerrero@volta-medical.com
• Phone: 612-227-1483

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.