The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
at least 1 electrocardiographically documented episode within 12 months prior to enrollment
Adults who are ≥18 and ≤80 years of age on the day of enrollment.
Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
AF that required three (3) or more distinct cardioversions in the preceding 12 months.
LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
Single group
Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
DevicePulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation
Freedom from documented recurrence of atrial fibrillation, atrial tachycardia, or atrial flutter based on electrocardiographic data through 12 months (365 days) and excluding a 90-day blanking period. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic trans-telephonic monitoring (TTM) transmissions through 12 months, and 12-lead ECGs at all follow up visits. Atrial tachyarrhythmia observed via any of those instruments, as well as acute procedural failure, repeat ablation, cardioversion, an increase in anti-arrhythmic drugs, or use of amiodarone at any time during the study will constitute a failure.
Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 Months
Primary safety events (device- and procedure-related serious adverse events, as adjudicated by the Clinical Events Committee) for the Sphere-360 Catheter and Affera Mapping and Ablation System: Within 7 days: heart block, major bleeding needing transfusion, MI, permanent phrenic nerve paralysis, pulmonary edema, severe pericarditis, significant effusion/tamponade, stroke/CVA, systemic/pulmonary embolism needing intervention, TIA, vagal nerve injury causing esophageal dysmotility/gastroparesis, vascular access complications needing intervention, AKI needing dialysis or hospitalization \>48h or prolonged \>48h, death, any device/procedure-related CV/pulmonary event causing/prolonging hospitalization \>48h (excludes recurrent AF/AT/AFL). Within 3 months: atrioesophageal/esophago-pericardial fistula, esophageal perforation (device/procedure related; excludes TEE/nasogastric tube injury). Within 6 months: pulmonary vein stenosis (≥70% diameter reduction).
Secondary Endpoint: Quality of Life (AFEQT)
Change in AFEQT score from baseline to 12 months. The AFEQT is an AF-specific health-related quality of life questionnaire, scored 0-100 (higher scores indicate better quality of life).
Secondary Endpoint: Quality of Life (EQ-5D)
Change in EQ-5D composite score from baseline to 12 months. The EQ-5D is a standardized instrument for generic health status, with composite scores indexed to a US reference population.
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