Migotanie przedsionków: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (32)

1. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
2. Known presence of cardiac thrombus
3. Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
4. New York Heart Association (NYHA) class III or IV heart failure
5. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
6. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
8. Unstable angina
9. Stroke or TIA (transient ischemic attack) within the last 90 days
10. Heart disease in which corrective surgery is anticipated within 180 days after procedure
11. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
12. Contraindication to long term anti-thromboembolic therapy
13. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
14. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
15. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
16. Previous tricuspid or mitral valve replacement or repair
17. Patients with prosthetic valves
18. Patients with a myxoma
19. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
20. Stent, constriction, or stenosis in a pulmonary vein
21. Rheumatic heart disease
22. Hypertrophic cardiomyopathy
23. Diagnosed with amyloidosis or atrial amyloidosis
24. Active systemic infection
25. Renal failure requiring dialysis
26. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
27. Presence of an implanted LAA closure device
28. Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
29. Unlikely to survive the protocol follow up period of 12 months
30. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
31. Individuals without legal authority
32. Individuals unable to read or write