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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05951101




Registration number
NCT05951101
Ethics application status
Date submitted
29/06/2023
Date registered
18/07/2023

Titles & IDs
Public title
Zenith LAA Occlusion System
Scientific 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)
Secondary ID [1] 0 0
CLN002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Left Atrial Appendage 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Zenith LAA Occlusion System

Experimental: Zenith LAA Occlusion System - Zenith LAA Occlusion System Implantation


Treatment: Devices: Zenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural success
Timepoint [1] 0 0
72 hours
Primary outcome [2] 0 0
Mechanical device closure
Timepoint [2] 0 0
45 days
Secondary outcome [1] 0 0
Device related thrombus
Timepoint [1] 0 0
45 days and 12 months
Secondary outcome [2] 0 0
SAE
Timepoint [2] 0 0
through study completion, an average of 1 year
Secondary outcome [3] 0 0
Stroke
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Thromboembolism
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Device closure
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Device use questionnaire
Timepoint [6] 0 0
up to 24 hours
Secondary outcome [7] 0 0
Changes in Quality of Life score according to SF-12 questionnaire
Timepoint [7] 0 0
Baseline, 45 days, 6 months and 12 months

Eligibility
Key inclusion criteria
1. Age =18 at the time of screening
2. Documented diagnosis of non-valvular AF
3. Clinical indication for LAA occlusion
4. Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol.
5. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Within 30 days before the procedure date:

1. Exhibited NYHA class III or IV heart failure symptoms
2. 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:
3. Documented history of myocardial infarction or unstable angina
4. Documented embolic stroke, TIA or suspected neurologic event
5. Chronic renal insufficiency (eGFR =15mL/min per 1.73 m2 (CKD-EPI)) or end-stage renal disease
6. Requires long-term oral anticoagulation therapy for a condition other than AF
7. Diagnosed active local or systemic infection, septicaemia, active pericarditis, or fever of unknown origin
8. Known acquired or inherited propensity for forming blood clots (e.g., malignancy and factor V Leiden mutation) established by prior objective testing
9. Contraindication to the standard of care post-implantation antithrombotic medication regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC)
10. Rheumatic heart disease
11. Implanted mechanical valve prosthesis
12. Documented carotid disease, defined as greater than 70% stenosis without symptoms or greater than 50% stenosis with symptoms
13. Body mass index greater than 40 kg/m2
14. Patient is pregnant or breastfeeding or plans/desires to get pregnant within the next 12 months post-procedure
15. 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
16. Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the study
17. 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
18. Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the Zenith LAA Occlusion System Implant
19. Life expectancy of less than 1 year
20. 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
21. 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
22. 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
23. Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not be suitable
24. Intracardiac thrombus diagnosed by CCTA or echocardiography
25. Previous occlusion/ligation of the LAA (by any surgical or percutaneous method)
26. 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
27. Documented Left Ventricular Ejection Fraction (LVEF) <30%

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AuriGen Medical Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Felix Mahfoud
Address 0 0
Internal Medicine and Cardiology, Saarland University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nuwani Edirisinghe
Address 0 0
Country 0 0
Phone 0 0
+447581155987
Fax 0 0
Email 0 0
nuwani.edirisinghe@aurigenmedical.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05951101