Status:
UNKNOWN
Left Atrial Appendage Closure in Combination With Catheter Ablation
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-90 years
Brief Summary
This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.
Detailed Description
This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation. This study will b...
Eligibility Criteria
Inclusion
- History of paroxysmal/persistent/longstanding persistent atrial fibrillation
- Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
- With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
- CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
- Provide informed consent to participate in the study;
- Between 18-90 years
Exclusion
- myocardial infarction within 3 months
- Stroke or systemic embolism within 3 months
- Plan to receive heart transplantation;
- Life expectancy less than 1 year;
- Severe bleeding diseases that cannot be treated with short-term anticoagulants;
- With left atrial or left atrial appendage thrombus;
- With uncontrolled malignant tumor ;
- Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr \<50%);
- Women who are pregnant, or breastfeeding.
- Other conditions not suitable to the combined procedure.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03788941
Start Date
January 1 2017
End Date
December 31 2024
Last Update
January 19 2023
Active Locations (1)
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1
Xinhua Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200092