Non-valvular atrial fibrillation
Conditions
Interventions
CT group:preprocedural Cardiac CTA, introprocedural DSA, postprocedural Cardiac CTA, undergo Cardiac CTA 3 & 12 month after LAAO
Control group:preprocedural Cardiac CTA, intraprocedural transesophageal echocardiography, postprocedural Cardiac CTA, undergo Cardiac CTA 3 & 12 month after LAAO
Sponsors
Senior Department of Cardiology, the Sixth Medical Centre, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age=18 yrs; (2) Paroxysmal, persistent or permanent nonvalvular atrial fibrillation; (3) CHA2DS2-VASc score = 2 for males and = 3 for females (C: congestive heart failure=1, H: hypertension=1, A: age = 75 years=2, D: diabetes=1, S: previous stroke / TIA/ thromboembolism history=2, V: vascular disease=1, A: age 65-74 years=1, Sc: female=1); (4) Oral anticoagulation contraindication or HAS-BLED score = 3 (1 score for any of the following items: hypertension with systolic blood pressure higher than 160mmHg, abnormal liver function, abnormal renal function, including lacunar stroke, history of hemorrhage or bleeding tendency, unstable international standard ratio, age > 65 years old, use of antiplatelet or non-steroidal anti-inflammatory drugs, alcohol overdose).
Exclusion criteria
Exclusion criteria: (1) Left atrial appendage thrombus; (2) Complex left atrial appendage(LAA) anatomy, e.g.early lobulation of LAA, average diameter of orifice > 30mm or < 14mm, anti-chicken wing type, etc. (3) Treacherous condition of atrial septal puncture complication, e.g. interatrial septal aneurysm; (4) Complicated with other diseases requiring long-term oral anticoagulation; (5) Absolute contraindication of transesophageal echocardiography; (6) CKD 4 not requiring dialysis, allergy or intolerance to contrast media; (7) Anatomical abnormalities, e.g. severe dilatation of aorta or malformation of pulmonary vein; (8) Unstable aortic plaques; (9) Symptomatic carotid artery disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of peridevice leak;Severe pericardial effusion;Total procedural duration;Measurement of Peri-device leak; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compression rate;Endothelialization;Procedural complications, such as air-embolism, cardiac valve injury, cardiac arrest etc.;Composite occurrence of all-cause death, stroke major adverse cardiovascularand cerebrovascular events (MACCE);Procedural manipulatory duration;Contrast Volume;Device Consumption;Device-related thrombus;Hospitalization Time;Atrial septal puncture times;Occluder Retrieved Times; | — |
Countries
China
Contacts
Public ContactJun Guo
Senior Department of Cardiology, the Sixth Medical Centre, Chinese PLA General Hospital, 6 Fucheng Road, Haidian District, Beijing 100037, China
Outcome results
None listed