Zenith LAA Occlusion System

NCT05951101 | Recruiting DMC

• 1 other identifier: CLN002
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

Atrial Fibrillation; Left Atrial Appendage; Stroke

Keywords

LAA Occlusion; Left Atrial Appendage; Atrial Fibrillation; LAA closure

Outcome Measures

Primary Outcomes (2)

• 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

• Mechanical device closure

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

  45 days

Secondary Outcomes (7)

• Device related thrombus

  45 days and 12 months

• SAE

  through study completion, an average of 1 year

• Stroke

  12 months

• Thromboembolism

  12 months

• Device closure

  6 months

Study Arms (1)

Zenith LAA Occlusion System

EXPERIMENTAL

Zenith LAA Occlusion System Implantation

Device: Zenith LAA Occlusion System

Interventions

Zenith LAA Occlusion System DEVICE

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

Zenith LAA Occlusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AuriGen Medical Ltd: lead

Study Sites (3)

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

NOT YET RECRUITING

Auckland City Hospital

Auckland, New Zealand

RECRUITING

Christchurch Hospital

Christchurch, New Zealand

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuwani Edirisinghe

CONTACT

+447581155987; nuwani.edirisinghe@aurigenmedical.com

John Thompson

CONTACT

+353 863525057; john.thompson@aurigenmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Implantation of Zenith LAA Occlusion System

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 18, 2023
• Study Start: March 28, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); AU (1)