A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
A physician's note indicating recurrent AF
At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
Suitable candidate for catheter ablation.
Continuous AF lasting more than 12 months (long-standing persistent AF).
AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).
Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).