Migotanie przedsionków: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (17)

1. Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
2. Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
3. Patients with heart prosthetic valves
4. Patient implanted with an inferior vena cava filter
5. Patients with left ventricular ejection fraction ≤30%
6. Patients with NYHA Class IV heart failure
7. Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)
8. Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure
9. Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)
10. Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
11. Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure
12. Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation
13. Patients with a stent, constriction, or stenosis in a pulmonary vein
14. Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
15. Patients with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
16. Patients with 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
17. Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)