Endocardial Mapping With the CoreMap EP Mapping System

Prior treatment

• Active drug or alcohol dependency

Other illness

• Any of the following within three months of enrollment:
  • Myocardial infarction (MI)
  • Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
  • Confirmed thrombus on imaging
• Any of the following within six months of enrollment:
  • Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
  • Thromboembolic event (stroke)
• AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• Renal failure requiring dialysis or transplant
• Acute illness, active systemic infection, or sepsis
• Hypertrophic cardiomyopathy or cardiac amyloidosis

Lab values

• Any of the following cardiac conditions:
  • New York Heart Association (NYHA) IV
  • Left ventricular ejection fraction (LVEF) \< 30%
  • Left atrial diameter \>55mm (anterioposterior) (Phase 3)
  • Carotid stenting or endarterectomy
  • Atrial or ventricular septal closure or left atrial appendage closure
  • Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
  • Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
  • Unstable angina
  • Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
  • Moderate to severe mitral valve stenosis or other severe valvular disease
  • Any blood clotting or bleeding abnormalities

Other

• Contraindication to systemic anticoagulation
• Body mass index (BMI) \> 40 kg/m2
• Cor pulmonale
• Any contra-indication that may extend procedure time, at the discretion of the operator
• 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
• Subject considered part of vulnerable population
• Life expectancy less than one year
• Employee of the study site or Sponsor
• Subjects who are currently enrolled in another study that would directly interfere with this study

• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures