A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator

Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.

Time frame: Immediately post-procedure on Day 1

Population: The per protocol analysis set included enrolled eligible participants who had undergone ablation using PF and/or RF energy via the investigational ablation system per clinical investigational plan (CIP), were treated for the study-related arrythmia, and without major CIP deviation that effected the scientific integrity of the safety and effectiveness.

Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.

Time frame: 90 days post-procedure on Day 1

Population: Modified intention-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria and had insertion of the study catheter. Here, 'N' (number of participants analyzed) refers to participants who were evaluable for this outcome measure.

Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia episodes including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\]30 seconds on arrhythmia monitoring device) were reported. Participants with an AF/AT/AFL (of unknown origin) episode that is \>=30 seconds on arrhythmia monitoring device during the evaluation period were considered failures of this long-term effectiveness outcome measure. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the targeted pulmonary vein \[PVs\]) were also deemed a failure of this outcome measure. AFL of unknown origin was defined as all AFL except those cavotricuspid isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an electrophysiology (EP) study.

Time frame: Day 91 to Day 365

Population: The per protocol analysis set included enrolled eligible participants who had undergone ablation using PF and/or RF energy via the investigational ablation system per clinical investigational plan (CIP), were treated for the study-related arrythmia, and without major CIP deviation that effected the scientific integrity of the safety and effectiveness. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.