The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
A physician's note documenting diagnosis of symptomatic PAF/PsAF, as defined above AND
PAF: At least one (1) AF episode electrocardiographically documented within 12 months prior to enrollment
PsAF: Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be more than (>) 365 days prior to enrollment) OR A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
Participant is aged 18-80 years at the time of informed consent
Participant has continuous AF > 365 days (longstanding persistent AF)
Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, et cetera)
Participant has previous surgical or catheter ablation for AF
Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and wolff-parkinson-white)
Parallel
VARIPULSE Catheter System (PVI)
DeviceVARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
VARIPULSE Catheter System (PVI and PWI)
DeviceVARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
Number of Participants with Early Onset Primary Adverse Events (PAEs)
PAEs include early onset AEs such as: * Esophageal perforating complications * Phrenic nerve paralysis (PNP; permanent) * Cardiac tamponade/perforation * Pulmonary vein stenosis (PVS) * Death (device or procedure related) * Stroke/ cerebrovascular accident (CVA) * Major vascular access complication/bleeding * Thromboembolism * Myocardial Infarction (MI) * Transient ischemic attack (TIA) * Pericarditis * Pulmonary edema (respiratory insufficiency) * Heart block * Vagal nerve injury/ gastroparesis
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (\<=) 0.1% and freedom from the following failure modes will be considered a success * Acute procedural failure * Repeat ablation failure * Surgical treatment for atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL) after the index ablation procedure * Non-study catheter (NSC) failure * Antiarrhythmic Drug (AAD) failure or any direct current (DC) cardioversion (DCCV) procedure during the evaluation period.
Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or \>=60 minutes on ILR arrhythmia monitoring) during the post-blanking period will be reported.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or \>=30 seconds on ILR arrhythmia monitoring) during the post-blanking period.
Number of Participants with Residual AA Burden <=0.1%
Number of participants with residual AA burden \<=0.1% in the post-blanking period, without any additional failure modes will be reported.
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