Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

Inclusion Criteria:

• 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF).
• 2. Subject must be ≥18 years of age.
• 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater.
• 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months.
• 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin.
• 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy.

Exclusion Criteria:

• 1. Subject who requires anticoagulation for a condition other than AF.
• 2. Subject with a New York Heart Association (NYHA) classification equal to IV.
• 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement.
• 4. Subject with valvular disease.