An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion
Objective 1: To evaluate the safety and effectiveness of the CLAAS Device by demonstrating non-inferiority to currently marketed Left Atrial Appendage Occlusion (LAAO) systems in subjects with non-valvular atrial fibrillation.
Objective 2: To demonstrate the safety of a post procedure pharmacologic antiplatelet regimen that consists of DAPT alone without concomitant oral anticoagulation therapy (OAC).
Objective 3: To demonstrate the ability to safely deliver the CLAAS Device using a conscious sedation protocol without general anesthesia. To investigate this objective, a separate Sub-Study will be conducted after recruitment of the Randomized Clinical Trial (RCT) is complete at select,
qualified sites based on the experience demonstrated in the RCT.
Objective 4: Support regulatory approval(s) in territories outside US.
Primary Investigator: Joseph Choo