The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
Willing and capable of providing consent
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
Previous surgical or catheter ablation for AF
Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
Current enrollment in an investigational study evaluating another device or drug
Single group
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
DevicePulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.
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