Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Time frame: Up to 7 days (post initial mapping and ablation procedure)

Population: The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.

A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Time frame: Up to 90 days (post initial mapping and ablation procedure)

Population: The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.

Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Time frame: Day 1

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Population included participants who had the adenosine/isoproterenol challenge.

Hospitalization was defined as prolonged stay greater than or equal to (\>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure \>= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.

Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.

A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

Time frame: Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)

Population: The population analysis included the mITT analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.

Time frame: Up to 405 Days

Population: NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants analyzed at specified time point.

Number of participants with new or worsening neurologic deficits was reported.

Time frame: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month

Population: Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants with neurological deficit at specified time point.

The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).

Time frame: Pre-procedure and at discharge (Up to 405 Days)

Population: NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI.

An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.

Time frame: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.

Time frame: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)

Population: Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and had post-ablation MRI. Here 'n' (number analyzed) signifies participants with MRI done at specified time point.

An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.

Time frame: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

Time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.

Number of participants with symptomatic and asymptomatic cerebral emboli was reported

Time frame: Up to 405 Days

Population: The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.

Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode \>30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.

Time frame: Up to 12 Months

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Percentage of participants with six-month arrythmia recurrence \[defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes \>30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)\] was reported.

Time frame: Up to 6 Months

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.

Time frame: Up to 405 Days

Population: PP analysis set included participants who were enrolled and met all eligibility criteria; had undergone RF ablation with study catheters; and were treated for the study-related arrhythmia. Here 'n' (number analyzed) signifies number of pulmonary veins (PV) in all evaluable participants analyzed at specified category.

Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.

Time frame: Up to 405 Days

Population: PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia.