A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared with Standard of Care Ablation in Patients with Paroxysmal Atrial Fibrillation

Brief description of study

The purpose of this study is to evaluate the safety and effectiveness of the study device that creates scar tissue at the sites where atrial fibrillation commonly begins in the heart. The FARAPULSE™ Pulsed Field Ablation System is used to create this scar tissue around the openings of the pulmonary veins in the heart. This ablation procedure will be performed in an electrophysiology lab at the hospital. This study is being carried out to investigate whether using the FARAPULSE™ Pulsed Field Ablation System helps to reduce the occurrence of paroxysmal atrial fibrillation.

Clinical Study Identifier: s20-01038
ClinicalTrials.gov Identifier: NCT04612244
Principal Investigator: Larry A Chinitz.
Other Investigator: Douglas S Holmes.

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