Stroke Feasibility Study

Completed

Phase 1/2 Results N/A

Trial Description

This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.

Conditions

Interventions

  • AtriClip LAA Exclusion Device Device
    Other Names: LAAØ; PRO1; AtriClip™ LAA Exclusion System; AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip; AtriClip LAA Exclusion System and Delivery System (LAAØ); AtriClip LAA Exclusion System and Delivery System (PRO1)
    ARM 1: Kind: Experimental
    Label: AtriClip LAA Exclusion Device
    Description: AtriClip delivered via minimally invasive surgical procedure

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Serious Adverse Events within 30 Days Post-Index Procedure 30 days post-index procedure Yes
Primary Composite Left Atrial Appendage Placement and Exclusion success Immediate to 3-months post-index procedure No
Secondary Rate of Stroke and Non-CNS systemic embolism 3 months and 6 months post-index procedure Yes
Secondary Serious Device or Procedure Related Adverse Event Rate 3 month and 6 month post-index procedure Yes
Secondary Overall Serious Adverse Event Rate 3 month and 6 month Post Index Procedure Yes
Secondary Overall Adverse Event Rate 3 month and 6 month post-index procedure Yes

Sponsors