Left Atrial Appendage Occlusion Study III

Atrial Fibrillation Clinical Trial

— LAAOS III  

Official title:

Left Atrial Appendage Occlusion Study III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561651
• Other study ID #: LAAOSIII-2012
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: May 2021

Study information

• Verified date: January 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works.

The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4812
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Greater than 18 years of age

2. Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass

3. Have a documented history of atrial fibrillation or atrial flutter

4. CHA2DS2-VASc score = 2

5. Have provided informed consent

Exclusion Criteria:

1. Patients undergoing off-pump cardiac surgery

2. Patients undergoing any of the following procedures:

• heart transplant

• complex congenital heart surgery

• sole indication for surgery is ventricular assist device insertion

• previous cardiac surgery requiring opening of the pericardium

• mechanical valve implant

3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Surgery With Cardiopulmonary Bypass

Intervention

Other:
• 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 patient's cardiac surgery procedure.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission for heart failure	Readmission for heart failure	Common termination point (median follow-up of 4 years)
Other	Post-operative safety outcomes	Operative safety outcomes (30-day mortality, chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding)	30 days post-surgery
Other	Major bleeding	Major bleeding	Common termination point (median follow-up of 4 years)
Other	Myocardial infarction	Myocardial infarction	Common termination point (median follow-up of 4 years)
Primary	Stroke or systemic arterial embolism	First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	Common termination point (median follow-up of 4 years)
Secondary	All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	Common termination point (median follow-up of 4 years)
Secondary	Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death	Ischemic stroke* or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death	Common termination point (median follow-up of 4 years)
Secondary	Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism > 30 days after surgery	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)
Secondary	Total mortality	Total mortality	Common termination point (median follow-up of 4 years)