Status:
UNKNOWN
Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appen...
Detailed Description
The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin since the sixth month a...
Eligibility Criteria
Inclusion
- Age between 18 and 90 years
- Paroxysmal, persistent, long-standing persistent or permanent nonvalvular AF
- Have already had a Watchman LAAO device implanted 6 months ago
Exclusion
- Clinical Exclusion Criteria
- Long-term aspirin therapy required
- Including coronary artery disease, symptomatic carotid disease, prior myocardial infarction, strokes or systemic embolism, etc
- Contraindicated for aspirin therapy
- Including active peptic ulcer, thrombocytopenia or anemia, etc.
- Uncontrolled malignant tumor
- Abnormal liver, renal or coagulation function
- Pregnant or pregnancy is planned during the course of the investigation
- Terminal illness with life expectancy \<1 year
- Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug
- TEE Exclusion Criteria\*
- Peri-device leak \>5mm
- Device-related thrombus
- Other intracardiac thrombus
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
1120 Patients enrolled
Trial Details
Trial ID
NCT03821883
Start Date
June 1 2020
End Date
December 1 2024
Last Update
October 12 2021
Active Locations (1)
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1
Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200092