Left Atrial Appendage Occlusion Study III

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Cardiac Surgery With Cardiopulmonary Bypass
• Interventions: Other: Left Atrial Appendage Occlusion

• Registration Number: NCT01561651
• Lead Sponsor: Population Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Study Start: 2012-07
• Primary Completion: 2021-04
• Study Completion: 2021-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4812

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Atrial Appendage Occlusion Group	Left Atrial Appendage Occlusion	Surgeon will close the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure device during the patient's cardiac surgery procedure.

Primary Outcome Measures

Name	Time	Method
Stroke or systemic arterial embolism	Common termination point (median follow-up of 4 years)	First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism

Secondary Outcome Measures

Name	Time	Method
All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism	Common termination point (median follow-up of 4 years)	All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
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 or death
Total mortality	Common termination point (median follow-up of 4 years)	Total mortality
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)	Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism \> 30 days after surgery

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada