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.

Left Atrial Appendage Occlusion Study III - LAAOS III

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011925

Enrollment

4700

Registered

2018-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- having Atrial Fibrillation Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass

Interventions

Intervention1: Left Atrial Appendage Occlusion: Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure during the pat

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Stroke or systemic arterial embolism 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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Iran (Islamic Republic of), Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, United Kingdom, United States of America

Contacts

Public ContactProf G Karthikeyan

All India Institute of Medical Sciences, New Delhi

karthik2010@gmail.com01126594464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026