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