A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Left Atrial Appendage Closure
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
- Subject must be ≥18 years of age.
- Subject has a calculated CHA2DS2-VASc score of 2 or greater, denoting a high risk for stroke or systemic embolism.
- 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
- Subject deemed appropriate for LAA closure by the Site Heart Team
- Subject is eligible for the post-procedural antithrombotic regimen per protocol
- 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:
- AF single episode or transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
- Recent (within 90 days pre-procedure) stroke or transient ischemic attack
- Subject with history of acute or recent myocardial infarction (MI) or unstable angina within 90 days
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or dialysis at the time of screening
- Active infection with bacteremia
- Active COVID-19 infection
- Cardiac tumor
- Subject with a history of pericarditis, rheumatic heart disease, or severe cardiac valvular disease
- 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)
- Severe heart failure (New York Heart Association Class III or IV)
- Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)
- Prior cardiac surgery, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
- Previous AF Ablation procedure in the 90 days before the LAMINAR procedure date
- Need for AF Ablation procedure to be performed less than 90 days from the LAMINAR procedure
- Subject with a history of coronary artery bypass graft (CABG) surgery
- Recent (within 30 days pre-procedure) or planned (within 60 days postprocedure) cardiac or non-cardiac interventional or surgical procedure
- Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
- Left ventricular ejection fraction (LVEF) <30%
- Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
- Atrial septal defect that warrants closure
- 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)
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
- Complex atheroma with mobile plaque of the aorta
- 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).
- Vascular access precluding delivery of implant with catheter-based system
- Subject with inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
- Patient is unable to undergo general anesthesia
- Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
- 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)
- The patient has contrast sensitivity that cannot be adequately premedicated
- Bleeding diathesis or coagulopathy
- Thrombocytopenia (platelet count <75,000 cells/mm3), thrombocytosis (>700,000 cells/mm3), or leukopenia (white blood cell count <3,000 cells/mm3)
- 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.
- 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
- Current participation in another investigational drug or device study
- 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)
Sites / Locations
- Tbilisi Heart and Vascular Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.
Outcomes
Primary Outcome Measures
Closure success using the Laminar Left Atrial Appendage Closure System
Confirmation of functional LAA closure as defined by absence of residual peri-device flow ≤ 5mm in width per transesophageal echocardiography.
Adverse Events
Rate of all cause-mortality and major adverse events (including procedure-related stroke, systemic embolism, life-threatening or major bleeding) and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05224375
Brief Title
A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Official Title
A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non- Valvular Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
April 5, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laminar, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative, to anticoagulant medications.
Detailed Description
Left atrial appendage closure (LAAC) is an approved therapy for stroke prevention in atrial fibrillation patients who are recommended for chronic oral anticoagulation therapy (OAC), but are non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants in accordance with evidence-based decision-making criteria and current scientific guidelines.
The objective of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation who are deemed appropriate for LAAC to reduce the risk of stroke and systemic embolism.
Patients will be followed for 12 months after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.
Intervention Type
Device
Intervention Name(s)
Left Atrial Appendage Closure
Intervention Description
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System
Primary Outcome Measure Information:
Title
Closure success using the Laminar Left Atrial Appendage Closure System
Description
Confirmation of functional LAA closure as defined by absence of residual peri-device flow ≤ 5mm in width per transesophageal echocardiography.
Time Frame
45 days
Title
Adverse Events
Description
Rate of all cause-mortality and major adverse events (including procedure-related stroke, systemic embolism, life-threatening or major bleeding) and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Time Frame
7 days and 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Subject must be ≥18 years of age.
Subject has a calculated CHA2DS2-VASc score of 2 or greater, denoting a high risk for stroke or systemic embolism.
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
Subject deemed appropriate for LAA closure by the Site Heart Team
Subject is eligible for the post-procedural antithrombotic regimen per protocol
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:
AF single episode or transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
Recent (within 90 days pre-procedure) stroke or transient ischemic attack
Subject with history of acute or recent myocardial infarction (MI) or unstable angina within 90 days
Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or dialysis at the time of screening
Active infection with bacteremia
Active COVID-19 infection
Cardiac tumor
Subject with a history of pericarditis, rheumatic heart disease, or severe cardiac valvular disease
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)
Severe heart failure (New York Heart Association Class III or IV)
Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)
Prior cardiac surgery, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
Previous AF Ablation procedure in the 90 days before the LAMINAR procedure date
Need for AF Ablation procedure to be performed less than 90 days from the LAMINAR procedure
Subject with a history of coronary artery bypass graft (CABG) surgery
Recent (within 30 days pre-procedure) or planned (within 60 days postprocedure) cardiac or non-cardiac interventional or surgical procedure
Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
Left ventricular ejection fraction (LVEF) <30%
Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
Atrial septal defect that warrants closure
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)
Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
Complex atheroma with mobile plaque of the aorta
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).
Vascular access precluding delivery of implant with catheter-based system
Subject with inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
Patient is unable to undergo general anesthesia
Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
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)
The patient has contrast sensitivity that cannot be adequately premedicated
Bleeding diathesis or coagulopathy
Thrombocytopenia (platelet count <75,000 cells/mm3), thrombocytosis (>700,000 cells/mm3), or leukopenia (white blood cell count <3,000 cells/mm3)
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.
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
Current participation in another investigational drug or device study
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)
Facility Information:
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
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