A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

Inclusion Criteria:

• Documented evidence of paroxysmal, persistent, or permanent non-valvular atrialfibrillation (NVAF)

• CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women

• Deemed to be clinically indicated for left atrial appendage (LAA) closure by theSite Investigator and a clinician not a part of the procedural team using anevidence-based decision-making tool in accordance with standard of care

• Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriaterationale to seek a non-pharmacologic alternative

• Eligible for the protocol-specified post-procedural antithrombotic regimen

• Willing and able to comply with the protocol, and has provided written informedconsent (participant or legally authorized representative) per institutional reviewboard (IRB) requirements

Exclusion Criteria:

• Single episode, transient, or reversible atrial fibrillation (AF) (example,secondary to thyroid disorders, acute alcohol intoxication, trauma, recent majorsurgical procedures)

• Prior cardiac surgery or any procedure that involved pericardial access

• Stage IV kidney disease or Renal insufficiency, defined as estimated glomerularfiltration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73square meters (m^2) or participants with end stage renal disease who are dialysisdependent

• Any cardiac or non-cardiac interventional or surgical procedures within 60 daysprior to or any planned general surgery, cardiac surgery, or interventionalprocedure within 60 days after implant (including, but not limited to cardioversion,percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)

• Left atrial appendage anatomy which cannot accommodate either commercially availablecontrol device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminardevice to be enrolled in the study)