Left Atrial Appendage Occlusion Study II (LAAOSII)

September 21, 2015 updated by: Richard Whitlock, Population Health Research Institute

Phase III Pilot Study - Left Atrial Appendage Occlusion Study

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
Procedure: 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.
Active Comparator: Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
Procedure: Best medical practice
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
Time Frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
Time Frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Sunnybrook Health Sciences Centre
McMaster University
London Health Sciences Centre
Université de Montréal

Investigators

  • Principal Investigator: Richard Whitlock, MD, FRCSC, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAAOSII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Surgical occlusion of the left atrial appendage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe