Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation

Exclusion Criteria

• •1. History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• •2. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy)
• •3. Presence of LA thrombus by TEE, CT scan, MRI, or angiography
• •4. Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity)
• •5. Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
• •6. Uncontrolled heart failure or NYHA Class III or IV heart failure
• •7. Valve repair or replacement or presence of a prosthetic valve
• •8. Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months
• •9. MI or PCI procedure within 3 months before screening
• •10. Left Ventricular Ejection Fraction (LVEF) \< 40%
• •11. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)
• •12. Severe pulmonary hypertension or prior pulmonary stenting
• •13. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
• •14. Contraindication to anticoagulation (e.g., heparin)
• •15. History of blood clotting or bleeding disease