Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation

Exclusion Criteria

• •1. Prior procedure involving opening of the pericardium or entering the pericardial space (e.g., coronary artery bypass graft (CABG), heart transplantation, valve surgery) where adhesions are suspected;
• •2. Measured LA diameter \> 6.5 cm;
• •3. Documented embolic stroke, Transient ischemic attack (TIA) or suspected neurologic event within 3 months prior to the planned intervention;
• •4. Currently exhibits New York Heart Association (NYHA) Class IV heart failure symptoms;
• •5. Documented history of right heart failure specifically when right ventricle exceeds the left ventricular size;
• •6. Documented history of myocardial infarction (MI) within 3 months prior to the planned study intervention;
• •7. Documented history of unstable angina within 3 months prior to the planned study intervention;
• •8. Recent documented history of cardiogenic shock, hemodynamic instability or any medical condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated;
• •9. Documented symptomatic carotid disease, defined as \> 70% stenosis or \> 50% stenosis with symptoms;
• •10. Diagnosed active local or systemic infection, septicemia or fever of unknown origin at time of baseline screening;
• •11. Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 within 3 months prior to study treatment;
• •12. End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;
• •13. Current documented history of clinically significant liver disease which predisposes the subject to significant bleeding risk (clinically defined by the treating physician);
• •14. Any history or thoracic radiation with the exception of localized radiation treatment for breast cancer;
• •15. Current documented use of long-term treatment with corticoid steroids, not including use of inhaled steroids for respiratory diseases;
• •16. Active pericarditis;
• •17. Active endocarditis;
• •18. Any documented history or autoimmune disease associated with pericarditis;
• •19. Evidence of Pectus Excavatum (documented and clinically defined by the treating physician);
• •20. Untreated severe scoliosis (documented and clinically defined by treating physician);
• •21. Thrombocytopenia (platelet count \< 100 x 109/L) based on most recent pre-procedure assessment within 30 days prior to planned intervention;
• •22. Anemia with hemoglobin concentration of \<8 g/dL based on most recent pre-procedure assessment (within 30 days prior to planned intervention);
• •23. Left Ventricular Ejection Fraction (LVEF) \< 30% within 30 days prior to planned intervention;
• •24. Known acquired or inherited propensity for forming blood clots (e.g., malignancy, Factor V leiden mutation) established by prior objective testing;
• •25. Documented presence of implanted congenital defect closure devices, (e.g., atrial septal device (ASD), patent foramen vale (PFO) or ventricular septal device (VSD) device);
• •26. Previously attempted occlusion of the LAA (by any surgical or percutaneous method);
• •27. Inability, unwillingness or contraindication to undergo TEE imaging;
• •28. Body Mass Index (BMI) \> 40;
• •29. Evidence of active Graves disease;
• •30. Current untreated hypothyroidism;
• •31. Any contraindication to suture, endovascular device, or other minimally invasive techniques including percutaneous, transseptal, and/or sub-xiphoid access.
• •32. Subject is pregnant or plans / desires to get pregnant within next 12 months;
• •33. Current enrollment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow up;
• •34. Mental impairment or other psychiatric conditions which may not allow patient to understand the nature, significance and scope of the study;
• •Subjects will also be excluded if they meet any of the following:
• •1. Based on screening computed tomography angiography (CTA) performed prior to study intervention:
• •* LAA Morphology: Superior-posterior oriented LAA (i.e. superior C shape), that has:
• •1. LAA LARIAT-approach width ≥ 40 mm; or
• •2. LAA distal apex extending posterior to the ostium of the LAA.
• •* LAA positioned behind the pulmonary artery; or
• •* All other LAA morphology: LAA LARIAT approach width \> 45 mm.
• •2. Based on a peri-procedural imaging (TEE at time of hybrid sub-X MAZE procedure. or catheter ablation):
• •* Intracardiac thrombus; or
• •* Significant mitral valve stenosis (i.e., mitral valve (MV) stenosis \< 1.5cm2)