Topic: Cardiovascular
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 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
Exclusion criteria: 1. Patients undergoing any of the following procedures: 1.1. Off-pump cardiac surgery 1.2. Heart transplant 1.3. Complex congenital heart surgery 1.4. Sole indication for surgery is ventricular assist device insertion 1.5. Previous cardiac surgery (reoperation) 1.6. Mechanical valve implantation 2. Patients who have had a previous placement of a percutaneous LAA closure device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First occurrence of stroke or systemic arterial embolism over the duration of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, England, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, Switzerland, United Kingdom, United States of America