Zenith LAA Occlusion System

Stroke Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951101
• Other study ID #: CLN002
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: AuriGen Medical Ltd
• Contact: Nuwani Edirisinghe
• Phone: +447581155987
• Email: nuwani.edirisinghe[@]aurigenmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =80 years 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%

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage
• Stroke

Intervention

Device:
• Zenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
AuriGen Medical Ltd

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mechanical device closure	Mechanical device closure - residual jet around the device =5 mm at 45 days by TOE	45 days
Secondary	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
Secondary	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
Secondary	Stroke	Ischemic stroke through 12 months	12 months
Secondary	Thromboembolism	Systemic thromboembolism through 12 months	12 months
Secondary	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
Secondary	Device use questionnaire	Use of the Zenith LAA Occlusion System per Device use questionnaire (Operator)	up to 24 hours
Secondary	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