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Left Atrial Appendage Occlusion Study II

NCT00908700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2015-09-23

No results posted yet for this study

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?

Conditions

Interventions

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.

PROCEDURE

Best medical practice

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

Sponsors & Collaborators

  • McMaster University

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Richard Whitlock, MD, FRCSC · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-11-30
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00908700 on ClinicalTrials.gov