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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/02/011925
• Date of registration: 15-02-2018
• Prospective Registration: No
• Primary sponsor: Population Health Research Institute
• Public title: 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.
• Scientific title: Left Atrial Appendage Occlusion Study III - LAAOS III
• Date of first enrolment: 24-08-2017
• Target sample size: 4700
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14877
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: Phase 2/ Phase 3

Countries of recruitment

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

• Name: Prof G Karthikeyan
• Affiliation: All India Institute of Medical Sciences, New Delhi

• Name: Prof G Karthikeyan
• Affiliation: All India Institute of Medical Sciences, New Delhi

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 patients cardiac surgery procedure.
Control Intervention1: No Left Atrial Appendage Occlusion: Surgeon will not close the left atrial appendage during the patients cardiac surgery procedure. Patient will be treated as per best medical practice for stroke prevention in atrial fibrillation. Treatment will be decided by the patients primary care physician.

Primary Outcome(s)

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 Outcome(s)

Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or deathTimepoint: Common termination point (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)

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

Secondary ID(s)

NCT01561651

Source(s) of Monetary Support

Population Health Research Institute (PHRI) DBCVSRI,237 Barton Street East Hamilton, Ontario,L8L2X2 Canada

Ethics review

Status: Approved
Approval date: 05/07/2016
Contact:

Institute Ethics Committee, All India Institute of Medical Sciences

Status: Approved
Approval date: 21/12/2016
Contact:

Institutional ethics Committee, SAL Hospital and Medical Institute

Status: Approved
Approval date: 21/02/2017
Contact:

Institutional Ethics Committee, G. Kuppuswamy Naidu Memorial Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences & Technology

Status: Not Approved
Approval date:
Contact:

Institutional Review Borad (research and ethics Committee), Christian Medical College

Status: Not Approved
Approval date:
Contact:

The Ethics Committee, Dr. Ram Manohar Lohia Hospital