Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Part of paid clinical trials in Evanston, Illinois.
- Sponsor
- Volta Medical
- Study ID
- NCT06056271
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AF Ablation — DEVICEPercutaneous, catheter-based ablation of atrial fibrillation
Study Details
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.
Key Dates
- Start date
- Mar 19, 2024
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 400 participants (estimated)
Primary Outcome Measure
Primary Clinical Efficacy Outcome [ Time Frame: 12 and 24 months ]
Central Contacts
- Daniel Guerrero612-227-1483
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Endeavor Health | Evanston | Illinois | 60201 | Research Coordinator |
| Kansas City Cardiac Arrhythmia Research LLC | Overland Park | Kansas | 66211 | Donita Atkins Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | New York | New York | 10075 | - |
| Ohio State University | Columbus | Ohio | 43210 | - |
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