Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation "ASAP-TOO"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Detailed Description

The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.
Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.

Conditions

Interventions

  • WATCHMAN LAAC Implant Device
    Intervention Desc: WATCHMAN LAAC Implant
    ARM 1: Kind: Experimental
    Label: WATCHMAN (Device)
    Description: WATCHMAN LAAC Device implant including modified post-implant drug regimen.
  • Single Antiplatelet Therapy of No Therapy Drug
    Intervention Desc: Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
    ARM 1: Kind: Experimental
    Label: Single antiplatelet therapy (Control)
    Description: Single antiplatelet therapy or no therapy at the discretion of the study physician for the duration of the trial.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary 7-Day Device/Procedural Safety Endpoint 7 days Yes
Primary Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism. 5 years No
Secondary The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism 5 years No
Secondary The occurrence of major bleeding (defined as a BARC Type 3 or 5 event) 5 years No
Secondary Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death 5 years
Secondary Secondary Endpoint - Major Bleeding 5 years

Sponsors