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

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ClinicalTrials.gov Identifier: NCT05478304
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : May 1, 2024
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
AtriCure, Inc.

Study Description
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Brief Summary:
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Systemic Embolism Device: AtriClip LAA Exclusion System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Actual Study Start Date : January 25, 2023
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : April 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
 Device: AtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
No Intervention: Control
No LAAE concomitant to and at the time of planned cardiac surgery


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: Common termination point (median follow-up for 5 years) ]
    Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.

  2. Primary Safety Endpoint [ Time Frame: 30 days post index procedure ]

    Occurrence of at least one of the following events assessed through 30 days post index procedure:

    • Pericardial effusion requiring percutaneous or surgical treatment
    • Major bleeding attributable to index surgical procedure
    • Deep sternal wound infection
    • Myocardial infarction


Secondary Outcome Measures :
  1. Powered Secondary Effectiveness endpoint [ Time Frame: Common termination point (median follow-up for 5 years) ]
    Time to the first occurrence of ischemic stroke or systemic arterial embolism


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ≥ 18 years of age

  • Documentation of any of the following clinical criteria:

    • CHA2DS2-VASc ≥ 4 with age ≥ 65
    • CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
    • CHA2DS2-VASc = 3 with age ≥ 75
    • CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
    • CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP

Exclusion Criteria:

  • Clinically significant atrial fibrillation or atrial flutter:

    • Anytime in the past and
    • Documented by an electrocardiographic recording and
    • Episode lasting 6 minutes or longer1*
  • Prior procedure involving opening the pericardium or entering the pericardial space
  • Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)

  • Planned cardiac surgical procedure using non-sternotomy approaches

    o Partial sternotomies will be allowed.

  • Patients whose planned procedure is 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 unsuitable candidate to complete the protocol required visits.
  • Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
  • Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
  • Pregnancy
  • Known severe symptomatic carotid disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05478304


Contacts
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Contact: Kirstin Smentek 612.430.1398 ksmentek@atricure.com
Contact: LeAAPS inbox LeAAPSTrial@atricure.com

Locations
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Sponsors and Collaborators
AtriCure, Inc.
Population Health Research Institute
Investigators
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Study Chair: Richard Whitlock, MD McMaster University
More Information
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT05478304    
Other Study ID Numbers: CP-2021-05
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Embolism
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis