The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than [>] 365 days prior to enrollment) or iii. 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 is willing and capable of providing informed consent
Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
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, etc.)
Participant has had previous surgical or catheter ablation for AF
Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
Parallel
VARIPULSE Catheter
DevicePulsed Field Ablation using the VARIPULSE catheter.
FARAWAVE Catheter
DevicePulsed field ablation using the FARAWAVE catheter.
Occurrence of Early Onset Primary Adverse Events (PAEs)
PAEs that 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, and vagal nerve injury/ gastroparesis.
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (\>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
Change From Baseline in Quality of life, As Measured by the Total 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.
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