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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,300
VARIPULSE™ 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 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.
Ascension Texas Cardiovascular
Austin, Texas, United States
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
Time frame: Up to 7 days post-procedure
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.
Time frame: Day 61 up to Day 365 post-procedure
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.
Time frame: Baseline to 12 months post-procedure
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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.
Time frame: Day 61 up to Day 365 post-procedure
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.
Time frame: Day 61 up to Day 365 post-procedure
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.
Time frame: Day 61 up to Day 365 post-procedure
Percentage of Residual AA Burden
Percentage of residual AA burden in the post-blanking period without any additional failure modes will be reported.
Time frame: Day 61 up to Day 365 post-procedure