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Atrial FibrillationNCT05951101

Zenith LAA Occlusion System

A study testing Zenith LAA Occlusion System in people with Atrial Fibrillation and Left Atrial Appendage, run by AuriGen Medical Ltd at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Left Atrial Appendage, Stroke
What is being tested?
Zenith LAA Occlusion System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesin 2 countries
Study dates
28 Mar 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Within 30 days before the procedure date:
  • 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])
  • Within 90 days before the procedure date:
  • Documented history of myocardial infarction or unstable angina
  • Documented embolic stroke, TIA or suspected neurologic event
Show all 30Show fewer
  • 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
  • Imaging Exclusion Criteria:
  • 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%

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Nuwani Edirisinghe contact

+447581155987

nuwani.edirisinghe@aurigenmedical.com

John Thompson contact

+353 863525057

john.thompson@aurigenmedical.com

3 sites in 2 countries

New Zealand2 sites, 2 recruiting

  • Auckland City Hospital

    Auckland

    Mandy Fish, +64 21 240 9349, mfish@adhb.govt.nz

    Matthew O'Connor, MA MB BChir FRACP

    Recruiting

  • Christchurch Hospital

    Christchurch

    Catherine Cruickshank, catherine.cruickshank@cdhb.health.nz

    Philip Adamson, MBChB PhD MPH FRACP FCSANZ

    Recruiting

Other trials in New Zealand

Australia1 site, 1 recruiting

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

    Diana C Velasquez, + 61 431983712, diana.velasquezreyes2@mh.org.au

    Matthew Brooks

    Not yet recruiting

Other trials in Australia

About this study

Official title: Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)

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

Read the detailed description

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.

Being tested
Zenith LAA Occlusion System
Keywords
LAA Occlusion, Left Atrial Appendage, Atrial Fibrillation, LAA closure
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zenith LAA Occlusion SystemDevice

    LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

Study groups in NCT05951101
Study groupRoleWhat they receive
Zenith LAA Occlusion SystemExperimentalZenith LAA Occlusion System Implantation
Receives: Device: Zenith LAA Occlusion System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural success

    Acute 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)

    Measured: 72 hours

  2. Mechanical device closure

    Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE

    Measured: 45 days

Secondary outcomes (7)

  1. Device related thrombus

    LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months

    Measured: 45 days and 12 months

  2. SAE

    All SAEs device and/or procedure-related post-procedure and to the end of the study

    Measured: through study completion, an average of 1 year

  3. Stroke

    Ischemic stroke through 12 months

    Measured: 12 months

  4. Thromboembolism

    Systemic thromboembolism through 12 months

    Measured: 12 months

  5. Device closure

    Mechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days)

    Measured: 6 months

  6. Device use questionnaire

    Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator)

    Measured: up to 24 hours

  7. Changes in Quality of Life score according to SF-12 questionnaire

    Patient-reported health quality at Baseline, 45 days, 6 months, and 12 months

    Measured: Baseline, 45 days, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start28 Mar 2024
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Implantation of Zenith LAA Occlusion System
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951101
Sponsor's protocol ID
CLN002
Status last verified
Oct 2024
First submitted
29 Jun 2023
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Zenith LAA Occlusion System in people with Atrial Fibrillation and Left Atrial Appendage, run by AuriGen Medical Ltd at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nuwani Edirisinghe (+447581155987, nuwani.edirisinghe@aurigenmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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