An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

mITT analysis set included all participants enrolled in the pivotal main phase who met eligibility criteria and had insertion of the study catheter. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on an electrocardiogram [ECG], sponsor-provided cardiac event monitor [CEM], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.

PP analysis set included all participants enrolled in the pivotal main phase who were treated for the study-related arrhythmia with the study catheter and without protocol deviations that would affect the scientific integrity of the study. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.

Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated Health Related Quality of Life (HRQoL) and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.

PP analysis aet included all participants enrolled in the pivotal main phase who were treated for the study-related arrhythmia with the study catheter and without protocol deviations that would affect the scientific integrity of the study. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated HRQoL and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus ([Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered*6])*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.

Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.