Sealing of the pouch attached with left upper chamber of heart during routine cardiac surgery for prevention of brain attack and other diseases caused by blood clots going to other orgnas.
Phase 2
- Conditions
- Health Condition 1: null- having Atrial Fibrillation Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
- Registration Number
- CTRI/2018/02/011925
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Age >= 18 years of age
2) Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
3) A documented history of atrial fibrillation or atrial flutter
4) CHA2DS2-VASc score >= 2
5) Written informed consent
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 requiring opening of the pericardium
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 Stroke or systemic arterial embolism <br/ ><br>First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolismTimepoint: Over the duration of follow-up (five years)
- Secondary Outcome Measures
Name Time Method All cause deathTimepoint: median follow-up of 4 years;All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolismTimepoint: median follow-up of 4 years;Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism 30 days after surgeryTimepoint: Common termination point (median follow-up of 4 years);Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or deathTimepoint: Common termination point (median follow-up of 4 years)