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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.