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Zenith LAA Occlusion System

RECRUITING

Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique. Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm.

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Study details:

The study objective is to demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Age ≥18 at the time of screening
  • Documented diagnosis of non-valvular AF
  • Clinical indication for LAA occlusion
  • Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol.
  • Willing and able to provide written informed consent
  • Exclusion criteria

  • Exhibited NYHA class III or IV heart failure symptoms
  • Known bleeding disorders (such as bleeding diathesis, thrombocytopenia [platelet count <100 X 109/L], severe anaemia [haemoglobin of <8 g/dL], or INR >2 [spontaneous])
  • Documented history of myocardial infarction or unstable angina
  • Documented embolic stroke, TIA or suspected neurologic event
  • Chronic renal insufficiency (eGFR ≤15mL/min per 1.73 m2 (CKD-EPI)) or end-stage renal disease
  • Requires long-term oral anticoagulation therapy for a condition other than AF
  • Diagnosed active local or systemic infection, septicaemia, active pericarditis, or fever of unknown origin
  • Known acquired or inherited propensity for forming blood clots (e.g., malignancy and factor V Leiden mutation) established by prior objective testing
  • Contraindication to the standard of care post-implantation antithrombotic medication regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC)
  • Rheumatic heart disease
  • Implanted mechanical valve prosthesis
  • Documented carotid disease, defined as greater than 70% stenosis without symptoms or greater than 50% stenosis with symptoms
  • Body mass index greater than 40 kg/m2
  • Patient is pregnant or breastfeeding or plans/desires to get pregnant within the next 12 months post-procedure
  • Current or planned enrolment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow-up
  • Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the study
  • Any other criteria (including physical and mental health), medical illness, or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site principal investigator
  • Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the Zenith LAA Occlusion System Implant
  • Life expectancy of less than 1 year
  • Inability, unwillingness, or contraindication to undergo Trans-Oesophageal and/or Trans-Thoracic Echocardiogram (TOE/TTE) or Cardiac Computed Tomography Angiography (CCTA) imaging or any catheterisation procedures
  • Any anatomical condition that precludes the patient from undergoing LAA occlusion with the AuriGen Zenith LAA Occlusion System implant procedure, as determined by the principal investigator
  • Patients with a maximal ostial left atrial appendage diameter >25 mm or <17 mm by pre-procedural ECG-gated CT scan, to fit the Zenith LAA Occlusion System
  • Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not be suitable
  • Intracardiac thrombus diagnosed by CCTA or echocardiography
  • Previous occlusion/ligation of the LAA (by any surgical or percutaneous method)
  • Documented presence of implanted closure devices (e.g. Atrial septal defect (ASD), Patent foramen ovale (PFO) or Ventricular septal defect (VSD) device) for congenital defect treatment
  • Documented Left Ventricular Ejection Fraction (LVEF) <30%
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-03-28

    Primary completion: 2025-01-31

    Study completion finish: 2025-12-31

    study type

    Study type

    DEVICE_FEASIBILITY

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05951101

    Intervention or treatment

    DEVICE: Zenith LAA Occlusion System

    Conditions

    • Stroke
    • Atrial Fibrillation
    • Left Atrial Appendage

    Find a site

    Closest Location:

    The Royal Melbourne Hospital

    Research sites nearby

    Select from list below to view details:

    • The Royal Melbourne Hospital

      Parkville, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Zenith LAA Occlusion System
    • Zenith LAA Occlusion System Implantation
    DEVICE: Zenith LAA Occlusion System
    • LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Procedural successAcute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any device or procedure related serious adverse events until the post-procedure discharge or 72 hours (whichever comes first)72 hours
    Mechanical device closureMechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE45 days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Device related thrombusLAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months45 days and 12 months
    SAEAll SAEs device and/or procedure-related post-procedure and to the end of the studythrough study completion, an average of 1 year
    StrokeIschemic stroke through 12 months12 months
    ThromboembolismSystemic thromboembolism through 12 months12 months
    Device closureMechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days)6 months
    Device use questionnaireUse of the Zenith LAA Occlusion System per Device use questionnaire (Operator)up to 24 hours
    Changes in Quality of Life score according to SF-12 questionnairePatient-reported health quality at Baseline, 45 days, 6 months, and 12 monthsBaseline, 45 days, 6 months and 12 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Zenith LAA Occlusion System

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