eft Atrial Appendage Occlusion Study III
Not Applicable
Recruiting
- Conditions
- Patients with atrial fibrillation/flutter undergoing on-pump cardiac surgery
- Registration Number
- JPRN-UMIN000019388
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4700
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients undergoing any of the following procedures: a. Off-pump cardiac surgery b. Heart transplant c. Complex congenital heart surgery d. Sole indication for surgery is ventricular assist device insertion e. Previous cardiac surgery (re-operation) f. Mechanical valve implantation 2) Patients who have had a previous placement of a percutaneous LAA closure device
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The first occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up.
- Secondary Outcome Measures
Name Time Method 1) total mortality 2) post-operative safety outcomes (chest tube output in the first 24 hours post-surgery, post-operative re-exploration for bleeding in the first 48 hours postsurgery, and 30-day mortality) 3) the incidence of re-hospitalization for heart failure 4) the incidence of major bleeding 5) the incidence of myocardial infarction