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

Korábbi kezelés

• 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
• Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
• 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
• 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.
• Current participation in another investigational drug or device study

Más betegség

• 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
• 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)
• 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
• 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)
• Bleeding diathesis or coagulopathy
• 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

Laborértékek

• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or dialysis at the time of screening
• Left ventricular ejection fraction (LVEF) <30%
• Thrombocytopenia (platelet count <75,000 cells/mm3), thrombocytosis (>700,000 cells/mm3), or leukopenia (white blood cell count <3,000 cells/mm3)

Egyéb

• Need for AF Ablation procedure to be performed less than 90 days from the LAMINAR procedure
• 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
• Subject with inferior vena cava (IVC) filter that would interfere with Laminar sheath insertion
• Patient is unable to undergo general anesthesia
• The patient has contrast sensitivity that cannot be adequately premedicated
• 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)

• 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)