CONFORM Pivotal Trial

Inclusion Criteria: 

1. Documented non-valvular AF (paroxysmal, persistent, or permanent)
2. High risk of stroke or systemic embolism, defined as CHADS2 score of >2 or CHA2DS2-VASc score of ≥3
3. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
4. Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation
5. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
6. Able to comply with the protocol-specified medication regimen and follow-up evaluations
7. The patient (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)

Exclusion Criteria:

1. Anatomic conditions that would prevent performance of an 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)
2. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
3. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
4. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
5. Documented active infection
6. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis noted at the site of prior treatment
7. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
8. Recent (within 30 days of index procedure) stroke or transient ischemic attack
9. Recent (within 30 days of index procedure) myocardial infarction
10. Vascular access precluding delivery of implant with catheter-based system
11. Severe heart failure (New York Heart Association Class IV)
12. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
13. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
14. Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3 
15. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) or that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
16. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
17. Unable to undergo general anesthesia
18. Known other medical illness or known history of substance abuse that may cause noncompliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
19. A condition which precludes adequate transesophageal echocardiographic (TEE) assessment