Observing outcomes of using AI during heart ablation for atrial fibrillation
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
This study looks at how well AI tools help doctors during heart procedures for atrial fibrillation and how these tools affect patients' outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Volta Medical Industry-sponsored |
| Locations | 4 sites (Evanston, Illinois and 3 other locations) |
| Trial ID | NCT06056271 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older who are indicated for AF ablation or have had the procedure within the last 24 months using the VX1 system.
Not a fit: Patients who are not indicated for catheter ablation or have AF due to a reversible cause may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of AF ablation procedures, leading to better patient outcomes.
How similar studies have performed: While this approach is observational, similar studies using AI in medical procedures have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Evanston, Illinois and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.