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).
Single group
SpherePVI™ Catheter
DeviceAffera SpherePVI™ Multi-Ablation System
Percentage of subjects experiencing a primary safety event
The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs) occurring within 7 days of the index ablation procedure: * Death * Myocardial infarction * Persistent phrenic nerve palsy * Transient ischemic attack (TIA) * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Major vascular access complications / bleeding * Heart block * Gastroparesis * Severe pericarditis * Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE * Cardiac tamponade / perforation (up to 30 days) * Pulmonary vein stenosis (up to 180 days) * Atrio-esophageal fistula (up to 180 days)
Percentage of subjects with acute procedure success
The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device. Acute electrical isolation of all pulmonary veins is defined as confirmation of entrance block in all targeted pulmonary veins.
Percentage of subjects experiencing a device- or procedure-related serious adverse event
The secondary safety outcome is the proportion of subjects experiencing device- or procedure-related serious adverse events (SAEs) as assessed at each follow-up visit
Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree")
Acute product performance will be evaluated during the procedure and includes the following: * SpherePVI™ Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired ablation sites * completion of ablation procedure * safe removal of catheter from the subject * Electroanatomical navigation and/or mapping sufficient to aid the procedure (if used) * Generation of acceptable acute ablation lesions * Acute block across linear ablation lines (e.g. CTI flutter line), if performed
Percentage of subjects free from documented recurrence outside of the blanking period
Chronic efficacy will be evaluated as freedom from documented arrhythmia recurrence outside of a 90-day blanking period. Failure will be reported as both (i) recurrence of AF and (ii) recurrence of any atrial tachyarrhythmia (AF, atrial tachycardia, or atrial flutter).
Percentage of pulmonary veins remaining isolated at remapping
Chronic efficacy may also be evaluated during an optional remapping procedure and will include the following: * The number of pulmonary veins that remain isolated * The number of patients with all pulmonary veins isolated * The number of previously ablated lines that remain blocked (when applicable)
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