Migotanie przedsionków: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (30)

1. Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
2. Subject has a prosthetic heart valve
3. Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
4. Previous surgical Maze procedure
5. Prior cardiac surgery (Redo)
6. Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
7. Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair.
8. Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
9. Class IV New York Heart Association (NYHA) heart failure symptoms
10. Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit
11. Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
12. Need for emergent cardiac surgery (i.e., cardiogenic shock)
13. Known carotid artery stenosis greater than 80%
14. Current diagnosis of active systemic infection
15. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
16. Renal failure requiring dialysis or hepatic failure
17. A known drug and/or alcohol addiction
18. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
19. Pregnancy or desire to get pregnant within 12-months of the study treatment
20. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
21. Subjects who have been treated with thoracic radiation
22. Subjects in current chemotherapy
23. Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
24. Subjects with known hypertrophic obstructive cardiomyopathy
25. Subjects with known cold agglutinin
26. History of abnormal bleeding and/or clotting disorder
27. Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
28. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
29. Body mass index > 40 kg/m2
30. Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study