Recruitment

Recruitment Status
Recruiting

Summary

Conditions
  • Atrial Fibrillation
  • Bleeding
  • Stroke
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").

This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").

Tracking Information

NCT #
NCT04394546
Collaborators
Not Provided
Investigators
Study Chair: Marty Leon, MD New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center Study Chair: Kenneth A Ellenbogen, MD Virginia Commonwealth University Principal Investigator: Shephal Doshi, MD Pacific Heart Institute and Providence St. John's Health Center Principal Investigator: Saibal Kar, MD HCA Healthhcare /Los Robles Health System