Evaluating a new device for closing the left atrial appendage in patients with atrial fibrillation

A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non- Valvular Atrial Fibrillation

This study is testing a new device to see if it can safely close a part of the heart in patients with atrial fibrillation who can’t take blood thinners, helping to prevent strokes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laminar, Inc. (Industry-sponsored)
• Locations: 1 site (Tbilisi)
• Trial ID: NCT05224375 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the Laminar Left Atrial Appendage Closure System in patients with non-valvular atrial fibrillation who cannot take anticoagulant medications. The trial will involve patients who are at high risk for stroke and have been deemed suitable for left atrial appendage closure as a non-pharmacologic alternative to chronic oral anticoagulants. Participants will be monitored for 12 months following the procedure to evaluate outcomes related to stroke prevention and overall safety.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with documented non-valvular atrial fibrillation and a CHA2DS2-VASc score of 2 or greater who are seeking alternatives to anticoagulant therapy.

Not a fit: Patients who are not eligible for left atrial appendage closure or those who do not have a high risk for stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer alternative for patients with atrial fibrillation who are unable to use anticoagulant medications, potentially reducing their risk of stroke.

How similar studies have performed: Previous studies on left atrial appendage closure have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

1. Subject with documented Non-Valvular AF, defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve.
2. Subject must be ≥18 years of age.
3. Subject has a calculated CHA2DS2-VASc score of 2 or greater, denoting a high risk for stroke or systemic embolism.
4. Subject is recommended for chronic oral anticoagulation therapy (OAC), but is non eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
5. Subject deemed appropriate for LAA closure by the Site Heart Team
6. Subject is eligible for the post-procedural antithrombotic regimen per protocol
7. Subject (or legally authorized representative, (where allowed)) has been informed of the nature of the study, agrees to its provisions, is willing and able to comply with the protocol-required medications and follow-up visits, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

1. AF single episode or transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
2. Recent (within 90 days pre-procedure) stroke or transient ischemic attack
3. Subject with history of acute or recent myocardial infarction (MI) or unstable angina within 90 days
4. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or dialysis at the time of screening
5. Active infection with bacteremia
6. Active COVID-19 infection
7. Cardiac tumor
8. Subject with a history of pericarditis, rheumatic heart disease, or severe cardiac valvular disease
9. Medical condition (other than AF) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
10. Severe heart failure (New York Heart Association Class III or IV)
11. Documented symptomatic carotid artery disease (\>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of \>70%)
12. Prior cardiac surgery, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
13. Previous AF Ablation procedure in the 90 days before the LAMINAR procedure date
14. Need for AF Ablation procedure to be performed less than 90 days from the LAMINAR procedure
15. Subject with a history of coronary artery bypass graft (CABG) surgery
16. Recent (within 30 days pre-procedure) or planned (within 60 days postprocedure) cardiac or non-cardiac interventional or surgical procedure
17. Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
18. Left ventricular ejection fraction (LVEF) \<30%
19. Circumferential pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
20. Atrial septal defect that warrants closure
21. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (exclusion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] or substantial passage of bubbles)
22. Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
23. Complex atheroma with mobile plaque of the aorta
24. Anatomic conditions that would prevent performance of a LAA occlusion procedure (e.g., prior atrial septal defect (ASD) or patent foramen ovale (PFO) surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
25. Vascular access precluding delivery of implant with catheter-based system
26. Subject with inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
27. Patient is unable to undergo general anesthesia
28. Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
29. Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium, gold) or that would preclude any P2Y12 inhibitor therapy (e.g., clopidogrel, ticlopidine, ticagrelor, prasugrel)
30. The patient has contrast sensitivity that cannot be adequately premedicated
31. Bleeding diathesis or coagulopathy
32. Thrombocytopenia (platelet count \<75,000 cells/mm3), thrombocytosis (\>700,000 cells/mm3), or leukopenia (white blood cell count \<3,000 cells/mm3)
33. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
34. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 2 years
35. Current participation in another investigational drug or device study
36. Vulnerable Patients groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of refusal to participate, such as students, residents, and employees)

Where this trial is running

Tbilisi

• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (Recruiting)

Study contacts

• Study coordinator: Bryan Petrisko, MS

Conditions Atrial Fibrillation