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

An Initial Assessment of the Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial Arrhythmias

A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias

Inclusion Criteria:

1. Age ≥ 18 and < 75 years.

2. 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.

3. Subject is able and willing to give informed consent.

4. Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

Exclusion Criteria:

1. Documented left atrial thrombus or another abnormality which precludes catheter introduction.

2. Documented ejection fraction (EF) < 40%.

3. Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant [NOAC]).

4. Unstable angina or ongoing myocardial ischemia.

5. Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.

6. Congenital heart disease where the underlying abnormality increases the risk of the ablation.

7. Pulmonary hypertension (mean pulmonary artery pressure [mPAP] > 50 mmHg)

8. Enrollment in any other ongoing study protocol that would interfere with this study.

9. Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) < 29ml/min.

10. Active gastrointestinal (GI) bleeding.

11. Active infection or sepsis.

12. Short life expectancy (< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.

13. Significant anemia (defined as hemoglobin < 8.0 gr/dL).

14. Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) > 200 mm Hg within last 30 days.

15. Severe bleeding, clotting or thrombotic disorder.

16. Uncontrolled diabetes.

17. Women who are pregnant or are not willing to use contraception for the duration of the study.

18. Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume [FEV1] <1)

19. Prior stroke or TIA within the last 6 months.

20. 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

21. Left atrial diameter of > 55 mm (parasternal view).

22. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.

23. Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness >1.5cm.

24. Prior ablation or surgery for atrial fibrillation.

25. NYHA Class III or IV