Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Volta Medical
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 wh…
Interventions
- DeviceAF Ablation
Percutaneous, catheter-based ablation of atrial fibrillation
Locations (4)
- Endeavor HealthEvanston, Illinois
- Kansas City Cardiac Arrhythmia Research LLCOverland Park, Kansas
- Northwell HealthNew York, New York
- Ohio State UniversityColumbus, Ohio