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Comparison of Two Pulse Field Ablation Systems for AF Ablation
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Summary
This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys.
Official title: Comparative Efficacy, Safety, and Efficiency of SYSTEM 1 Versus SYSTEM 2 Pulse Field Ablation Systems for Atrial Fibrillation Ablation Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-07-10
Completion Date
2031-05-30
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Pulse Field Ablation
Pulse Field Ablation
Locations (1)
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States