Applause Study I - Append System Early Feasibility Study

Inclusion criteria

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, permanent or non-rheumatic valve-related AF)
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
• The subject is eligible for the defined protocol medication regimen of anticoagulation and antiplatelet therapy following Append procedure.
• The patient is deemed appropriate for LAA ligation by the screening committee and the investigator.
• The patient has been informed of the nature of the study, agrees to its provisions \& follow-up evaluations, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
• General

Exclusion criteria

• 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.
• Atrial fibrillation that is defined by a single occurrence or that is considered to be reversible (e.g., due to thyroid disorders, acute alcohol intoxication, trauma, or recent major surgical procedures).
• Patients with an indication for chronic oral anticoagulation other than AF (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
• Clinically significant Severe heart failure (New York Heart Association functional class IV)
• Prior cardiac surgery or surgery requiring sternotomy
• Recent (within 3 months pre-procedure) stroke or transient ischemic attack.
• Recent (within 3 months pre-procedure) myocardial infarction
• Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) cardiac interventional procedures (e.g., percutaneous coronary intervention, structural heart valve procedures, etc.)
• Planned (within 60 days after the index procedure) cardiac surgical procedures or any surgeries which require sternotomy.
• Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) noncardiac procedures or surgical interventions.
• History of symptomatic pericarditis (acute or chronic).
• Patient has evidence of cardiac tumor
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening
• Platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3 or known Bleeding diathesis
• Active infection with bacteremia
• Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
• Current participation in another investigational drug or device study that would interfere with this study
• Patient is unable to undergo general anesthesia
• Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) or computed tomographic (CT) assessment.
• Known other medical illness or known history of substance abuse that may cause non-compliance with the specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years.
• Cardiac Imaging Exclusion Criteria:
• Intracardiac thrombus observed during screening
• Left ventricular ejection fraction (LVEF) \<30%
• Circumferential pericardial effusion \>5 mm or signs / symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
• Distance from inter-atrial septum fossa ovalis to LAA ostium is less than 40 mm
• Any anatomy or prior intervention that would preclude a transseptal approach (including, but not limited to, prior IVC filter placement that cannot be crossed, prior ASD, or prior PFO closure device implantation that precludes transseptal puncture)
• LAA structure that in the opinion of the screening committee / investigator precludes intervention