Left Atrial Appendage Occlusion Study II "LAAOSII"

Completed

Phase 3 Results N/A

Trial Description

A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.
Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.
Main research questions:
1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?

Detailed Description

The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.
LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.

Conditions

Interventions

  • Surgical occlusion of the left atrial appendage Procedure
    Other Names: Surgical occlusion of the left atrial appendage
    Intervention Desc: Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
    ARM 1: Kind: Experimental
    Label: Occlusion arm
    Description: Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
  • Best medical practice Procedure
    Intervention Desc: Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
    ARM 1: Kind: Experimental
    Label: Medical arm
    Description: Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication. Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) Yes
Secondary Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding. Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) Yes

Sponsors