Left Atrial Appendage Occlusion Study II (LAAOSII)

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Stroke

Treatments: Procedure: Surgical occlusion of the left atrial appendage; Procedure: Best medical practice

Study type: Interventional

Funder types: Other

Identifiers

NCT00908700

LAAOSII

Details and patient eligibility

About

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?

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass

• A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:

  • age => 65 years
  • hypertension
  • diabetes mellitus, or
  • heart failure/left ventricular ejection fraction < 50%

Exclusion criteria

• Patients in whom surgical AF ablation (MAZE or otherwise) is planned
• Planned "off-pump" surgery
• Planned implantation of a mechanical valve
• Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Occlusion arm

Experimental group

Description:

Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.

Treatment:

Procedure: Surgical occlusion of the left atrial appendage

Medical arm

Active Comparator group

Description:

Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Treatment:

Procedure: Best medical practice