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(352) 733-0111

LeAPPS

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Protocol number OCR42878
ClinicalTrials.gov ID NCT05478304
Phase N/A

Eligibility

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

Lead researcher

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.