The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).
Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
Age 18-75 years
Continuous AF greater than (>) 12 months (1-Year) (Longstanding Persistent AF)
Previous surgical or catheter ablation for atrial fibrillation
Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention [PCI])
Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
Single group
Pulsed Field Ablation System
DevicePulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.
Acute Effectiveness
Acute effectiveness, that is, acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported.
Pulmonary Vein Isolation (PVI) Durability
PVI durability is defined as sustained isolation of pulmonary vein (PVs) that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 (+/- 14 days) days post index ablation procedure.
Pulsed Field (PF) Application Time
PF application time will be reported.
Number of PF applications by PV
Number of PF applications by PV will be reported.
Occurrence of Serious Adverse Device Effects (SADE) (Within Seven (7) days) of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan
A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)
An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants.
Occurrence of SAEs
An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Occurrence of Non-Serious Adverse Events (Non-SAEs)
An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
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