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Completed

NCT Number: NCT00908700

Left Atrial Appendage Occlusion Study II

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?

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical occlusion of the left atrial appendage

Procedure

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

Best medical practice

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

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

Registry information

Official study title

Phase III Pilot Study - Left Atrial Appendage Occlusion Study

Acronym: LAAOSII

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
May 27, 2009
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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