Zenith LAA Occlusion System

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation; Left Atrial Appendage
• Intervention / Treatment: Device: Zenith LAA Occlusion System

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuwani Edirisinghe; Phone Number: +447581155987; Email: nuwani.edirisinghe@aurigenmedical.com
• Study Contact Backup: Name: John Thompson; Phone Number: +353 863525057; Email: john.thompson@aurigenmedical.com

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Not yet recruiting
      • The Royal Melbourne Hospital
      • Contact: Diana C Velasquez; Phone Number: + 61 431983712; Email: diana.velasquezreyes2@mh.org.au
      • Contact: Matthew Brooks
      • Contact: Will Wilson
• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Auckland City Hospital
    • Contact: Mandy Fish; Phone Number: +64 21 240 9349; Email: mfish@adhb.govt.nz
    • Contact: Matthew O'Connor, MA MB BChir FRACP
    • Contact: Andrew Martin
  • Christchurch, New Zealand
    • Recruiting
    • Christchurch Hospital
    • Contact: Catherine Cruickshank; Email: catherine.cruickshank@cdhb.health.nz
    • Contact: Philip Adamson, MBChB PhD MPH FRACP FCSANZ
    • Contact: Richard Troughton
    • Contact: Ian Crozier
    • Contact: Geoffrey Clare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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 Exclusion Criteria:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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 Measures

Outcome Measure	Measure Description	Time Frame
Mechanical device closure	Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE	45 days
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)	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE	All SAEs device and/or procedure-related post-procedure and to the end of the study	through study completion, an average of 1 year
Stroke	Ischemic stroke through 12 months	12 months
Thromboembolism	Systemic thromboembolism through 12 months	12 months
Device closure	Mechanical device closure - residual jet around the device ≤5 mm at 6 months (if it is not achieved at 45 Days)	6 months
Device use questionnaire	Use 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 questionnaire	Patient-reported health quality at Baseline, 45 days, 6 months, and 12 months	Baseline, 45 days, 6 months and 12 months
Device related thrombus	LAAO device-related thrombus as assessed by TOE at 45 days and by CCTA at 12 months	45 days and 12 months

Collaborators and Investigators

• Sponsor: AuriGen Medical Ltd
• Investigators: Principal Investigator: Felix Mahfoud, Internal Medicine and Cardiology, Saarland University Hospital; Principal Investigator: Christian Ukena, Saarland University Hospital; Principal Investigator: Sandeep Panikker, University Hospitals Coventry & Warwickshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Left Atrial Appendage; LAA Occlusion; LAA closure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No