Status:
RECRUITING
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Lead Sponsor:
Volta Medical
Collaborating Sponsors:
Heart Rhythm Clinical and Research Solutions, LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
21+ years
Brief 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 dur...
Eligibility Criteria
Inclusion
- 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
- Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
Exclusion
- Patients not indicated or were not indicated for catheter ablation according to current guidelines
- Patients with AF secondary to an obvious reversible cause
- Patients who are or may potentially be pregnant
- Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Key Trial Info
Start Date :
March 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06056271
Start Date
March 19 2024
End Date
December 1 2027
Last Update
December 10 2025
Active Locations (4)
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1
Endeavor Health
Evanston, Illinois, United States, 60201
2
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States, 66211
3
Northwell Health
New York, New York, United States, 10075
4
Ohio State University
Columbus, Ohio, United States, 43210