A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)

Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to \[\>=\] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram \[ECG\]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.

Time frame: From Day 91 up to Day 365 post-procedure on Day 0

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula .

Time frame: Within 7 days post-procedure on Day 0

Population: Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated.

Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and \>30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc.

Time frame: From day of procedure (Day 0) up to 12 months

Population: Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated.

Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure.

Time frame: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.

Time frame: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported.

Time frame: On day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator.

Time frame: From the day of procedure (Day 0) up to 12 months

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.

Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.

Time frame: On the day of procedure (Day 0)

Population: Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices.