Left Atrial Appendage Occlusion Study III "LAAOS III"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Left Atrial Appendage Occlusion Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Left Atrial Appendage Occlusion Group
    Description: Surgeon will close the left atrial appendage using a suture and/or a surgical stapler during the patient's cardiac surgery procedure.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke or non-CNS systemic embolism Common termination point (median follow-up of 4 years) No
Secondary Total mortality Common termination point (median follow-up of 4 years) No
Secondary Operative safety outcomes 30 days post-surgery Yes
Secondary Readmission for heart failure Common termination point (median follow-up of 4 years) No
Secondary Major bleed Common termination point (median follow-up of 4 years) No
Primary Stroke or systemic arterial embolism Common termination point (median follow-up of 4 years) No
Secondary All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism Common termination point (median follow-up of 4 years) No
Secondary Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death Common termination point (median follow-up of 4 years) No
Secondary 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) No

Sponsors