A Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Laminar, Inc.
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Closure success using the Laminar Left Atrial Appendage Closure System
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Closure success using the Laminar Left Atrial Appendage Closure System
Time Frame: 45 days
Confirmation of functional LAA closure as defined by absence of residual peri-device flow ≤ 5mm in width per transesophageal echocardiography.
Adverse Events
Time Frame: 7 days and 45 days
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.