CHAMPION-AF Clinical Trial
Last updated on July 2021Recruitment
- 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