Left Atrial Appendage Occlusion Study II

NCT ID: NCT00908700

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-11-30

Brief Summary

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

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Occlusion arm

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

Group Type: EXPERIMENTAL

Surgical occlusion of the left atrial appendage

Intervention Type: PROCEDURE

Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.

Medical arm

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

Group Type: ACTIVE_COMPARATOR

Best medical practice

Intervention Type: PROCEDURE

Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Interventions

Surgical occlusion of the left atrial appendage

Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.

Intervention Type: PROCEDURE

Best medical practice

Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Richard Whitlock

Cardiovascular Surgeon, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Whitlock, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

LAAOSII

Identifier Type: -

Identifier Source: org_study_id