Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Prior treatment

• Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure).
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure.
• Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
• Known drug or alcohol dependency.

Other illness

• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause.
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure.
• Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• History of blood clotting or bleeding abnormalities.
• Any condition contraindicating chronic anticoagulation.
• Uncontrolled heart failure or NYHA Class III or IV heart failure.
• Rheumatic heart disease.
• Unstable angina.
• Primary pulmonary hypertension.
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Renal failure requiring dialysis.
• History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention.
• Acute illness, active systemic infection, or sepsis.

Lab values

• Left ventricular ejection fraction (EF) \< 35%.

Other

• Continuous AF lasting for 12 months or longer.
• Any carotid stenting or endarterectomy.
• Documented left atrial thrombus on imaging.
• Body mass index \>40 kg/m2.
• Left atrial diameter \>55 mm (anterioposterior).
• Diagnosed atrial myxoma.
• Hypertrophic cardiomyopathy.
• Moderate to severe mitral valve stenosis.
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Contraindication to both computed tomography and magnetic resonance angiography.
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical study results.
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
• Life expectancy less than 12 months.
• Vulnerable subject (such as a prisoner or handicapped or mentally disabled person).

• Symptomatic PerAF documented by (1) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND either (2a) a 24-hour Holter documenting continuous AF within the past year OR (2b) two electrocardiograms (from any form of rhythm monitoring, including consumer devices) taken at least 7 days apart within the past year, each showing continuous AF.
• Failure or intolerance of at least one Class I or III anti-arrhythmic drug (AAD).
• Suitable candidate for catheter ablation.
• Adults aged 18 - 80 years.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
• Willing and able to provide informed consent.