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A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.
- atrial fibrillation
- failed drug treatment
- Left ventricular ejection fraction < 40%
- Implantable cardiac devices
- Heart surgery or stroke within 6 months of enrollment
- Renal impairment
- Body mass index greater than 40
FARAPULSE Pulsed Field Ablation System
For more information, visit the U.S. National Library of Medicine clinical trial database.
Key Participation Requirements
Male or Female
18 to 75
Active, Not Recruiting
Methodist Health System Trial Code