[Trial of device that is not approved or cleared by the U.S. FDA]

Withheld

Phase N/A Results N/A

Trial Description

Conditions

Interventions

  • AMPLATZER Cardiac Plug Device
    Intervention Desc: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
    ARM 1: Kind: Experimental
    Label: Device
    Description: AMPLATZER Cardiac Plug
    ARM 2: Kind: Experimental
    Label: Warfarin
    Description: Warfarin Drug
    ARM 3: Kind: Experimental
    Label: Optimal Medical Therapy (control)
    Description: Warfarin Dabigatran

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 45 Day Serious Adverse Event Rate 45 days Yes
Primary Acute Safety Randomization until Hospital Discharge Yes
Primary Long-term safety Randomization to 2 year follow-up Yes
Primary Effectiveness endpoint Randomization through 2 year follow up No
Secondary Acute clinical success In-hospital to 45 days post procedure Yes
Secondary Long-term clinical success Implant to at least 6 months follow-up Yes
Secondary Adverse Events Randomization through required follow-ups Yes
Secondary Atrial Fibrillation Status Randomization through required follow-ups No
Secondary Technical success Procedure No
Secondary Complete Closure 6 month No

Sponsors