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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS)

Atrial Fibrillation | Stroke | Atrial Flutter | Left Atrial Appendage

The purpose of this trial is to test if closing off the left atrial appendage (LAA) with a surgical device known as the AtriClip® reduces stroke occurrence in patients who do not have atrial fibrillation (AF), but have one or more risk factors for developing AF in the next 5 years. To properly answer this question, patients who are scheduled for heart surgery, such as artery bypass or valve replacement surgery, and have one or more risk factors for developing AF will be screened and considered to participate. Patients who meet all the trial requirements and agree to participate will be enrolled.

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Participation Requirements

  • Sex:

    Any

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:
• Must be ≥ 18 years of age
• Must be undergoing a planned and clinically indicated open heart surgery
• Must be at high risk of developing atrial fibrillation (a type of cardiac arrhythmia) after surgery and be at a high risk for post-operative stroke – these pre-existing risks will be calculated by the study team prior to enrollment into the study.
Exclusion Criteria:
• Clinically significant atrial fibrillation or atrial flutter
• Prior open-heart surgery or left atrial appendage occlusion, exclusion, or removal (surgical or percutaneous)
• Planned cardiac surgical procedure using non-sternotomy approaches
• Patients undergoing a heart transplant or implantation of any ventricular assist devices
• Active endocarditis
• Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
• Known allergy to Nitinol or nickel sensitivity
• Known medical condition with expected survival of less than 1 year
• Other comorbidities that, in the investigator’s opinion, make the subject an unsuitable candidate to complete the protocol required visits.

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Dr. Michael Moon

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780-407-6861
Primary Contact

Nasim Boroumand

[email protected]
780-407-2667
Primary Contact

Tracy Jordan

[email protected]
780-407-1470
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00134963