Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Prior treatment

• Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
• Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor.
• Known drug or alcohol dependency.

Other illness

• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or 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 12 months following the initial ablation procedure.
• Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
• 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.
• Acute illness, active systemic infection, or sepsis.

Lab values

• Left ventricular ejection fraction (EF) \< 40%.

Other

• Subjects will not be eligible for the study if any of the following criteria are met:
• Continuous AF lasting more than 12 months (long-standing persistent AF).
• Any carotid stenting or endarterectomy.
• Documented left atrial thrombus on imaging.
• Body mass index \>40 kg/m2.
• Left atrial diameter (anteroposterior) \>50 mm for paroxysmal AF and \>55mm for persistent AF.
• 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).
• 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 trial 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.

• Symptomatic paroxysmal or persistent atrial fibrillation (PAF) documented by:
  • 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.
• Age ≥ 18 and \< 75 years.
• Able and willing to give informed consent.
• Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements.