| CTRI Number |
CTRI/2018/02/011925 [Registered on: 15/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
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 of Study
|
Left Atrial Appendage Occlusion Study III |
| Trial Acronym |
LAAOS III |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01561651 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof G Karthikeyan |
| Designation |
Professor of Cardiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 24, 7th Floor,Cardio-Thoracic Sciences Center, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
01126594464 |
| Fax |
|
| Email |
karthik2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof G Karthikeyan |
| Designation |
Professor of Cardiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 24, 7th Floor,Cardio-Thoracic Sciences Center, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
01126594464 |
| Fax |
|
| Email |
karthik2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof G Karthikeyan |
| Designation |
Professor of Cardiology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 24, 7th Floor,Cardio-Thoracic Sciences Center, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
01126594464 |
| Fax |
|
| Email |
karthik2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Population Health Research Institute (PHRI) DBCVSRI,237 Barton Street East Hamilton, Ontario,L8L2X2 Canada |
|
|
Primary Sponsor
|
| Name |
Population Health Research Institute |
| Address |
Hamilton Health Sciences/McMaster University
237 Barton St. E.
Hamilton, ON L8L 2X2
Canada |
| Type of Sponsor |
Other [Public University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
Czech Republic
Ecuador
Egypt
France
Germany
Greece
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 |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Karthikeyan |
All India Institute of Medical Sciences |
Room no. 24, 7th Floor, Department of Cardiology, AIIMS, Ansari Nagar, Delhi 110029
South
DELHI |
011-26594464
karthik2010@gmail.com |
| Dr Vinayak Shukla |
Christian Medical College |
Cardio Thoracic Surgery, Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004
Vellore
TAMIL NADU |
0416-2282106
shukla58@hotmail.com |
| Dr Ranjit K Nath |
Dr. Ram Manohar Lohia Hospital & PGIMER |
Room no 232, Dept. of Cardiology, Dr. Ram Manohar Lohia Hospital & PGIMER, Baba Kharak Singh Marg, New Delhi - 110001
New Delhi
DELHI |
011-23404531
ranjitknath@yahoo.com |
| Dr Chandrasekhar |
G. Kuppusawmy Naidu Memorial Hospital |
PB No. 6327, Netaji Rd, Pappanaickenpalayam, Coimbatore, Tamil Nadu, 641037
Coimbatore
TAMIL NADU |
9443047152
chanpad@gmail.com |
| Dr Rajan Modi |
SAL Hospital & Medical Institute |
Room 812 8th Floor, Clinical Research Department, SAL Hospital and Medical Institute, OPP. Doordarshan drive in road, Thaltej
Ahmadabad
GUJARAT |
079-40327647
drrajanmodi@gmail.com |
| Dr Jayakumar Karunakaran |
Sri Chitra Tirunal Institute of Medical Sciences and Technology |
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) Dept of CardioVascular and Thoracic Surgery, Medical College PO, Thiruvananthapuram,
Kerala
695011
Thiruvananthapuram
KERALA |
9846034084
dr_jay_k@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, G. Kuppuswamy Naidu Memorial Hospital |
Approved |
| Institutional ethics Committee, SAL Hospital and Medical Institute |
Approved |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences & Technology |
Submittted/Under Review |
| Institutional Review Borad (research and ethics Committee), Christian Medical College |
Submittted/Under Review |
| The Ethics Committee, Dr. Ram Manohar Lohia Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
having Atrial Fibrillation Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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. |
| Comparator Agent |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stroke or systemic arterial embolism
First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism |
Over the duration of follow-up (five years) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism |
median follow-up of 4 years |
| Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death |
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 surgery |
Common termination point (median follow-up of 4 years) |
| All cause death |
median follow-up of 4 years |
|
|
Target Sample Size
|
Total Sample Size="4700"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/07/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Healey, J.S., et al., Left Atrial Appendage Occlusion Study (LAAOS): results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke. Am Heart J, 2005. 150(2): p. 288-93. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective is to examine the impact of LAA occlusion on the incidence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up in patients with atrial fibrillation undergoing cardiac surgery with the use of cardiopulmonary bypass.
The primary clinical hypothesis is that patients who have had their LAA occluded/removed will benefit over those on usual care alone. |