Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. PAEs included myocardial infarction, thromboembolism, transient ischemic attack, phrenic nerve paralysis, major vascular access complication/bleeding, pericarditis, pulmonary edema (respiratory insufficiency), stroke/cerebrovascular accident (CVA), hospitalization (initial or prolonged), device or procedure related death, atrio-esophageal fistula, pulmonary vein stenosis.

Time frame: Within 7 days post-procedure (Day of procedure = Day 0)

Population: Roll-in arm: Roll-in analysis set- participants who were enrolled in the roll-in phase and had undergone the radiofrequency (RF) delivery with the study catheters. Main study arm: Modified intent-to-treat (mITT) analysis set- enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. N (overall number of participants analyzed): participants evaluable for this outcome measure. Participants with missing values were excluded from the analysis.

Effectiveness success 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 (example, entrainment or activation mapping) in an EP study.

Time frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participant's HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1 to 18 evaluated HRQoL and questions 19 to 20 related to participant's satisfaction with treatment. Overall scores ranged from 0 to 100, where 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome 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). Therefore, a positive change in score corresponds to improvement in QoL. Total score was calculated using AFEQT formula: 100 minus (\[sum of severity for all questions answered minus number of questions answered\]\*100 / total number questions answered\*6).

Time frame: Baseline, Month 12

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed): participants evaluable for this outcome measure.

12-month single procedure success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (\>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) 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 DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.

Time frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

12-month symptomatic recurrence endpoint is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (\>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) in participants regardless of antiarrhythmic drug (AAD) use 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 DC Cardioversion failure, and freedom from recurrence (captured on 12-lead ECG) failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.

Time frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

Acute procedural success is defined as confirmation of entrance block in clinically relevant pulmonary veins (PVs) (all PVs except those that were silent and/or could not be cannulated) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

Time frame: Day 0 (day of procedure)

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.

Alternative 12-month success is defined as freedom from documented symptomatic AF/AT/AFL (of unknown origin) episodes based on electrocardiographic data (\>=30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365) 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 DC Cardioversion failure, freedom from recurrence (captured on 12-lead ECG) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin is defined as all AFL except those CTI dependent AFL as confirmed by accepted EP maneuvers (e.g. entrainment or activation mapping) in an EP study.

Time frame: From Day 91 up to Day 365 post-procedure (Day of procedure = Day 0)

Population: Roll-in arm: Roll-in analysis set defined as all participants who were enrolled in the roll-in phase and had undergone the RF delivery with the study catheters. Main study arm: mITT analysis set defined as enrolled participants who met eligibility criteria and had insertion of the Biosense Webster HELIOSTAR catheter. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.