Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation with the BWI IRE Ablation System
Brief description of study
The purpose of this study is to provide information about the safety and long-term effectiveness of the BWI irreversible electroporation (IRE) ablation system consisting of the TRUPULSE™ Generator and VARIPULSE™ Catheter. The BWI IRE Ablation system is indicated to be used for the treatment of Paroxysmal Atrial Fibrillation (PAF) in subjects who have failed at least one antiarrhythmic drug (medication to treat symptoms of PAF). The BWI IRE Ablation system is an investigational device that has not been approved by the FDA for the treatment of PAF.
Clinical Study Identifier: s21-01460
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