Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Endeavor Health
RECRUITING
Evanston
Kansas
Kansas City Cardiac Arrhythmia Research LLC
RECRUITING
Overland Park
New York
Northwell Health
RECRUITING
New York
Ohio
Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Daniel Guerrero
daniel.guerrero@volta-medical.com
612-227-1483
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2027-12
Participants
Target number of participants: 400
Related Therapeutic Areas
Sponsors
Collaborators: Heart Rhythm Clinical and Research Solutions, LLC
Leads: Volta Medical