Reducing stroke rates using left atrial appendage occlusion
| ISRCTN | ISRCTN17698102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17698102 |
| ClinicalTrials.gov (NCT) | NCT01561651 |
| Protocol serial number | 19759 |
| Sponsor | Imperial College Healthcare NHS Trust |
| Funder | Canadian Institutes of Health Research |
- Submission date
- 09/03/2016
- Registration date
- 10/03/2016
- Last edited
- 07/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Atrial fibrillation (AF) is a common heart condition, affecting millions of people worldwide. The heart consists of two upper chambers (atria) and two lower chambers (ventricles). Inside the right atrium, a cluster of cells (sinus node) are responsible for firing electrical signals into the heart muscle causing the heart to beat regularly (sinus rhythm). When a person is suffering from AF, the normal signals from the sinus node do not work properly, causing other parts of the atria to fire chaotically. These uncoordinated signals cause the heart to beat irregularly and often very fast (arrhythmia). People suffering from AF have a much higher risk of developing other problems, such as stroke. Prevention of stroke in people with AF is usually achieved using blood thinning medications such as colchicine however this is not always effective and there is a risk of serious bleeding. The left atrial appendage is a small structure in the muscle wall of the left atrium and is thought to be the most common source of blood clots causing stroke in patients with AF. Left atrial appendage closure (LAAC) is a treatment strategy which has been an area of interest in the field of stroke prevention. Blocking off (occluding) this structure during surgery using a suture (stitch) or surgical stapler, could be an effective method of stroke prevention in these patients, removing the need to take blood thinners. The aim of this study is to find out whether left atrial appendage occlusion can help to lower the occurrence of stroke in AF patients.
Who can participate?
Adults with AF who are having heart surgery involving a cardiopulmonary bypass.
What does the study involve?
Participants are randomly allocated to one of two groups. For those in the first group, during their surgery, the surgeon will block off (occlude) the left atrial appendage using a suture (stitch) and/or surgical stapler. For those in the second group, the left atrial appendage is not closed during surgery. Participants in both groups are followed up in order to find out which group has the higher occurrence of stroke.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Hammersmith Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2015 to December 2017
Who is funding the study?
Canadian Institutes for Health Research (UK)
Who is the main contact?
1. Mr Sajiram Sarvananthan (public)
s.sajiram@imperial.ac.uk
2. Mr Prakash Punjabi (scientific)
p.punjabi@imperial.ac.uk
Contact information
Public
Imperial College Healthcare NHS Trust
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 7949 554467 |
|---|---|
| s.sajiram@imperial.ac.uk |
Scientific
Hammersmith Hospital
Department Of Cardiothoracic Surgery
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 208 383 2026 |
|---|---|
| p.punjabi@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Left Atrial Appendage Occlusion Study III (LAAOS III) |
| Study objectives | The aim of this study is to examine the impact of left atrial appendage occlusion on the incidence of stroke or systemic arterial embolism in patients with atrial fibrillation undergoing cardiac surgery over the duration of follow up. |
| Ethics approval(s) | 15/LO/0769 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiac Surgery |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure during the patient's cardiac surgery procedure. Control group: Surgeon will not close the left atrial appendage during the patient's cardiac surgery procedure. |
| Intervention type | Other |
| Primary outcome measure(s) |
First occurrence of stroke or systemic arterial embolism over the duration of follow-up. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 4700 |
| Total final enrolment | 4811 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/11/2015 |
| Date of final enrolment | 04/09/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Colombia
- Czech Republic
- Egypt
- Germany
- Greece
- Hong Kong
- India
- Iran
- Ireland
- Italy
- Japan
- Malaysia
- Netherlands
- New Zealand
- Poland
- Portugal
- Russian Federation
- Spain
- Switzerland
- United States of America
Study participating centre
Du Cane Road
London
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/06/2021 | 07/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/06/2022: Publication reference added.
04/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2017 to 04/09/2018.
2. The overall trial end date has been changed from 31/12/2017 to 30/04/2021.
3. The intention to publish date has been changed from 31/12/2017 to 15/05/2021.
4. The final enrolment number has been added.
5. Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, Switzerland and the United States of America have been added to the cxountries of recruitment.
6. The ClinicalTrials.gov number has been added.
18/10/2017: Internal review.
24/06/2016: Mr Prakash P Punjabi has been added as a study contact.
