Atrial fibrillation
Conditions
Interventions
1:Combined atrial fibrillation catheter ablation and left atrial appendage occlusion procedure
Sponsors
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Chinese people aged 65-85 year-old; 2. Paroxysmal atrial fibrillation or persistent atrial fibrillation lasting for less than 3 years; 3. No previous histroy of atrial fibrillation catheter ablation; 4. CHA2DS2-VASc risk score of 2 or more; 5. Have signed the informed consent; 6. Be willing and be able to finish the follow-up visit as scheduled.
Exclusion criteria
Exclusion criteria: 1. Have a history of left atrial catheter ablation or surgical ablation; 2. Structural heart disease, including congenital heart disease, cardiac valve disease (moderate or severe, or prior metallic prosthetic heart valve replacement), hypertrophic cardiomyopathy; 3. Reversible causes of AF including but not limited to hyperthyroidism; 4. Myocardial infarction within 3 months prior to enrollment; 5. Patient has contra-indication to oral anticoagulation, heparin or low molecular weight heparins; 6. Left atrial diameter = 60 mm (2D echocardiography, parasternal long axis view); 7. Life expectancy = 2 years due to all kinds of reasons; 8. Abnormal liver or renal function; 9. High risk of accidental falls; 10. Low Treatment compliance; 11. Symptomatic carotid artery disease; 12. Need long term anticoagulation for reasons other than atrial fibrillation; 13. Proved to have thrombus, tumor or other disease that might affect the catheter placement in the atrium.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year all-cause mortality post procedure;1-year ischemic stroke rate post procedure;1-year systemic embolism rate post procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of bleeding in 1 year post procedure;The time free from any AF/AT (ECG confirmed) without AADs (except for ß blockers) between the 3rd month to the 12th month post procedure; | — |
Countries
China
Contacts
Public ContactChenyang Jiang
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Outcome results
None listed