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NCT Number: NCT01561651

Left Atrial Appendage Occlusion Study III

Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works.

The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.

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Key information

Conditions

Cardiac Surgery With Cardiopulmonary Bypass Arrhythmias, Cardiac Atrial Fibrillation 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

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Greater than 18 years of age
  • Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
  • Have a documented history of atrial fibrillation or atrial flutter
  • CHA2DS2-VASc score ≥ 2
  • Have provided informed consent

Exclusion criteria

  • Patients undergoing off-pump cardiac surgery
  • Patients undergoing any of the following procedures:
  • heart transplant
  • complex congenital heart surgery
  • sole indication for surgery is ventricular assist device insertion
  • previous cardiac surgery requiring opening of the pericardium
  • mechanical valve implant
  • Patients who have had a previous placement of a percutaneous left atrial appendage closure device

Treatment and study plan

Left Atrial Appendage Occlusion

Other

Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure during the patient's cardiac surgery procedure.

Primary outcomes

  1. Stroke or systemic arterial embolism

    Time frame: Common termination point (median follow-up of 4 years)

    First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism

Secondary outcomes

  1. All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism

    Time frame: Common termination point (median follow-up of 4 years)

    All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism

  2. Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death

    Time frame: Common termination point (median follow-up of 4 years)

    Ischemic stroke* or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death

  3. Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism > 30 days after surgery

    Time frame: Common termination point (median follow-up of 4 years)

    Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism > 30 days after surgery

  4. Total mortality

    Time frame: Common termination point (median follow-up of 4 years)

    Total mortality

Other outcomes

  1. Readmission for heart failure

    Time frame: Common termination point (median follow-up of 4 years)

    Readmission for heart failure

  2. Post-operative safety outcomes

    Time frame: 30 days post-surgery

    Operative safety outcomes (30-day mortality, chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding)

  3. Major bleeding

    Time frame: Common termination point (median follow-up of 4 years)

    Major bleeding

  4. Myocardial infarction

    Time frame: Common termination point (median follow-up of 4 years)

    Myocardial infarction

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Acronym: LAAOS III

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2012
Registry last updated
Jan 13, 2022

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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