Endocardial Mapping With the CoreMap EP Mapping System

Exclusion Criteria

• •1. Any of the following within three months of enrollment:
• •1. Myocardial infarction (MI)
• •2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• •3. Confirmed thrombus on imaging
• •2. Any of the following within six months of enrollment:
• •1. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• •2. Thromboembolic event (stroke)
• •3. Any of the following cardiac conditions:
• •1. New York Heart Association (NYHA) IV
• •2. Left ventricular ejection fraction (LVEF) \< 30%
• •3. Left atrial diameter \>55mm (anterioposterior) (Phase 3)
• •4. Carotid stenting or endarterectomy
• •5. Atrial or ventricular septal closure or left atrial appendage closure
• •6. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• •7. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• •8. Unstable angina
• •9. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
• •10. Moderate to severe mitral valve stenosis or other severe valvular disease
• •11. Any blood clotting or bleeding abnormalities
• •4. Contraindication to systemic anticoagulation
• •5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• •6. Body mass index (BMI) \> 40 kg/m2
• •7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• •8. Renal failure requiring dialysis or transplant
• •9. Acute illness, active systemic infection, or sepsis
• •10. Active drug or alcohol dependency
• •11. Hypertrophic cardiomyopathy or cardiac amyloidosis
• •12. Cor pulmonale
• •13. Any contra-indication that may extend procedure time, at the discretion of the operator
• •14. 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
• •15. Subject considered part of vulnerable population
• •16. Life expectancy less than one year
• •17. Employee of the study site or Sponsor
• •18. Subjects who are currently enrolled in another study that would directly interfere with this study