Zenith LAA Occlusion System

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)

Overview

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

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.

Interventions

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

Primary outcome measures

• Procedural success [Time frame: 72 hours]
• Mechanical device closure [Time frame: 45 days]

Secondary outcome measures (7)

• Device related thrombus [Time frame: 45 days and 12 months]
• SAE [Time frame: through study completion, an average of 1 year]
• Stroke [Time frame: 12 months]
• Thromboembolism [Time frame: 12 months]
• Device closure [Time frame: 6 months]
• Device use questionnaire [Time frame: up to 24 hours]
• Changes in Quality of Life score according to SF-12 questionnaire [Time frame: Baseline, 45 days, 6 months and 12 months]

Eligibility criteria

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

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
• 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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

New Zealand · 2 centers

• Auckland City Hospital — Auckland
• Christchurch Hospital — Christchurch

Australia · 1 center

• The Royal Melbourne Hospital — Parkville

Identifiers

NCT: NCT05951101 · CLN002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗