aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation

Inclusion Criteria:

   - Documented diagnosis of symptomatic continuous persistent or longstanding persistent
   non-valvular atrial fibrillation

   - Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible
   and intended for standard of care catheter ablation;

   - Life expectancy ≥ 1 year;

   - Willing and able to return to and comply with scheduled follow-up visits and tests;
   and

   - Willing and able to provide written informed consent

Exclusion Criteria:

   - Prior procedure involving opening of the pericardium or entering the pericardial space
   (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where
   adhesions are suspected;

   - Any prior epicardial ablation or any type of left-sided atrial ablation procedure;

   - LA diameter > 6 cm as measured by computerized tomography and confirmed by the imaging
   core laboratory;

   - Documented embolic stroke, transient ischemic attach or suspected neurologic event
   within 3 months prior to the planned study intervention;

   - Currently exhibits New York Heart Association Class IV heart failure symptoms;

   - Documented history of right heart failure specifically when right ventricle exceeds
   the left ventricular size;

   - Documented history of myocardial infarction (MI) within 3 months prior to the planned
   study intervention;

   - Documented history of unstable angina within 3 months prior to the planned study
   intervention;

   - Documented history of cardiogenic shock, hemodynamic instability or any medical
   condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated
   within 3 months prior to the planned study intervention;

   - Documented symptomatic carotid disease, defined as > 70% stenosis or > 50% stenosis
   with symptoms;

   - Diagnosed active local or systemic infection, septicemia or fever of unknown origin at
   tme of baseline screening;

   - Chronic renal insufficiency defined as eGFR < 30 mL/min/1.73m2 within 3 months prior
   to planned study intervention;

   - End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;

   - Current documented history of clinically significant liver disease which predisposes
   the subject to significant bleeding risk (clinically defined by the treating
   physician);

   - Any history of thoracic radiation with the exception of localized radiation treatment
   for breast cancer;

   - Current documented use of long-term treatment with oral corticoid steroids, not
   including use of inhaled steroids for respiratory diseases;

   - Active pericarditis;

   - Active endocarditis;

   - Any documented history or autoimmune disease associated with pericarditis;

   - Evidence of Pectus Excavatum (documented and clinically defined by the treating
   physician);

   - Untreated severe scoliosis (documented and clinically defined by treating physician);

   - Documented Left Ventricular Ejection Fraction (LVEF) < 30% within 30 days prior to
   planned intervention;

   - Documented presence of implanted congenital defect closure devices, (e.g., atrial
   septal defect, patent foramen ovale or ventricular septal defect device);

   - Previously attempted occlusion of the left atrial appendage (by any surgical or
   percutaneous method);

   - Inability, or unwillingness or contraindication to undergo TEE or CTA imaging or
   24-hour Holter monitoring;

   - Body Mass Index (BMI) > 40;

   - Evidence of active Graves disease;

   - Current untreated hypothyroidism;

   - Any contraindication to suture, endovascular device, or other minimally invasive
   techniques including percutaneous, transseptal, and/or sub-xiphoid access;

   - Subject is pregnant or plans / desires to get pregnant within next 12 months;

   - Current enrollment in an investigation or study of an investigational device or
   investigational drug that would interfere with this study and the required follow up;

   - Mental impairment or other psychiatric conditions which may not allow patient to
   understand the nature, significance and scope of the study;

   - Any other criteria, medical illness or comorbidity which would make the subject
   unsuitable to participate in this study as determined by the clinical site Primary
   Investigator;

Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging

Subjects will also be excluded if they meet any of the following:

   - Based on screening computed tomography angiography performed within 90 days prior to
   study intervention as confirmed by the core lab:

      - Left atrial appendage morphology: Superior-posterior oriented left atrial
      appendage (i.e. superior C shape), that has Left atrial appendage distal apex
      extending posterior to the ostium of the appendage.

      - Left atrial appendage positioned behind the pulmonary artery; or

      - All other left atrial morphology: Left atrial appendage LARIAT approach width >
      50 mm.

   - Based on a peri-procedural imaging (transesophageal echocardiography) at time of
   LARIAT or catheter ablation) and confirmed by institution's designated LARIAT
   echocardiographer:

      - Intracardiac thrombus; or

      - Significant mitral valve stenosis (i.e., mitral valve stenosis < 1.5cm2)

NOTE: It is anticipated that a majority of subjects enrolled in the aMAZE Trial will be
elderly US Medicare beneficiaries. Therefore, the results from the aMAZE Trial are expected
to be generalizable to the Medicare population.