An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Left Atrial Appendage Closure: Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System.
Study summary
This is an early feasibility 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documented non-valvular atrial fibrillation (AF), defined as AF (paroxysmal, persistent, or permanent) in the absence of moderate-to-severe mitral stenosis or a mechanical heart valve
* Participant greater than or equal to (\>=)18 years old
* CHA2DS2-VASc score \>=2 in men and \>= 3 in women
* Participant is recommended for chronic oral anticoagulation therapy (OAC) but is not eligible or has an appropriate rationale to seek a non-pharmacologic alternative to chronic OAC
* Participant deemed appropriate for LAA closure by the Site Heart Team using an evidenced based decision-making tool
* Participant eligible for the protocol-specified post-procedural antithrombotic regimen
* Participant or Legally Authorized Representative informed of the nature of the study, is willing and able to comply with the protocol, and has provided written informed consent per Institutional Review Board (IRB) requirements
Exclusion Criteria:
* Single episode, transient, or reversible AF (for example, secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
* Stroke or transient ischemic attack within 90 days before the index procedure
* Myocardial infarction or unstable angina within 90 days before the index procedure
* Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<)30 milliliters per minute (mL/min)/1.73 sqaure meter (m\^2), or dialysis at the time of screening
* Active infection with bacteremia
* Confirmed coronavirus disease 2019 (COVID-19) infection within 10 days before the index procedure Coexisting Cardiovascular Disease
* Cardiac tumor
* History of mitral valve or other severe cardiac valvular disease requiring intervention or presence of prosthetic mechanical valve
* 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 IV)
* Symptomatic carotid artery disease (greater than \[\>\] 50 percent \[%\] diameter reduction with prior ipsilateral stroke or transient ischemic attack \[TIA\]) or asymptomatic carotid artery disease (diameter reduction of \>70%) Previous or Planned Interventions
* Previous AF ablation procedure in the 90 days before the index procedure date or need for AF ablation to be performed in less than 90 days after the index procedure
* Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) cardiac or non-cardiac interventional or surgical procedure
* Intracardiac thrombus or dense spontaneous echo contrast visualized by transesophageal echocardiographic (TEE) within 2 days before the index procedure
* 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
* Complex atheroma with mobile plaque of the aorta
* Interatrial communication, atrial septal defect, or patent foramen ovale that warrants closure
* Vascular access precluding delivery of implant with catheter-based system
* Presence of inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
* Participant unable to undergo general anesthesia
* Participant with condition which precludes adequate TEE assessment
* Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium)
* Contrast sensitivity that cannot be adequately pre-medicated
* Thrombocytopenia , thrombocytosis, or leukopenia values as specified in protocol
* Pregnant or nursing and those who plan pregnancy in the period up to 1 year following the index procedure. Participants of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days before 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 1 year
* Current participation in another investigational drug or device study that in the opinion of the investigator could confound the data interpretation
Primary outcome measure(s)
Composite Adverse Events — 45 days Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Composite Adverse Events — 12 months Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
LAA Closure Rate — 45 days Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
LAA Closure Rate — 12 months Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
LAA Closure Rate — 45 days Rate of LAA closure per CCTA evaluated by independent core laboratory. Contrast patency defined as LAA density ≥100 HU or ≥25% of that of the left atrium.
Composite of Ischemic Stroke or System Embolism — 12 months Composite of ischemic stroke or systemic embolism.
Trial sites (7)
Facility
City
Region
Status
Tucson Medical Center
Tucson
Arizona
St. Bernard's Heart & Vascular
Jonesboro
Arkansas
Scripps Health
La Jolla
California
Univeristy of California Davis Health
Sacramento
California
Cardiovascular Institute Los Robles Hospital and Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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