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 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;

- 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;

- Body Mass Index (BMI) > 40. Investigator may petition for independent adjudication
based on subject body habitus;

- 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.