An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System

Inclusion criteria

• Age ≥ 18 and < 75 years.
• Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:

• Atrial Flutter defined as

o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.

OR

• Atrial Fibrillation defined as
• History of symptomatic paroxysmal and/or persistent atrial fibrillation within the past year documented by EKG AND
• Failure of at least one class I-IV drug as evidenced by recurrent symptomatic AF, or intolerable to AAD.
• Subject is able and willing to give informed consent.
• Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

Exclusion criteria

• Documented left atrial thrombus or another abnormality which precludes catheter introduction.
• Documented ejection fraction (EF) < 40%.
• Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).
• Unstable angina or ongoing myocardial ischemia.
• Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
• Congenital heart disease where the underlying abnormality increases the risk of the ablation.
• Pulmonary hypertension (mean pulmonary artery pressure [mPAP] > 50 mmHg)
• Enrollment in any other ongoing study protocol that would interfere with this study.
• Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) < 29ml/min.
• Active gastrointestinal (GI) bleeding.
• Active infection or sepsis.
• Short life expectancy (< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
• Significant anemia (defined as hemoglobin < 8.0 gr/dL).
• Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within last 30 days.
• Severe bleeding, clotting or thrombotic disorder.
• Uncontrolled diabetes.
• Women who are pregnant or are not willing to use contraception for the duration of the study.
• Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] <1)
• Prior stroke or TIA within the last 6 months.
• Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.

Additional exclusion criteria for AF patients only

• Left atrial diameter of > 55 mm (parasternal view).
• Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
• Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.
• Prior ablation or surgery for atrial fibrillation.
• NYHA Class III or IV