Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.

Detailed Description

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12 months between the continuous monitoring arm and the control arm in subjects with a recent ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the control arm will be followed per site specific standard of care.

Conditions

Interventions

  • Reveal LINQ™ Insertable Cardiac Monitor Device
    Other Names: LINQ; LINQ™
    Intervention Desc: The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.
    ARM 1: Kind: Experimental
    Label: Continuous Monitoring Arm
    Description: Subjects randomized to the continuous monitoring arm will have a Reveal LINQ ICM inserted.
    ARM 2: Kind: Experimental
    Label: Reveal LINQ™ Insertable Cardiac Monitor
    Description: Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Rate of AF through 12 months. 12 months No
Secondary Rate of AF through the duration of study follow-up between study arms. 3 years No
Primary Rate of atrial fibrillation through 12 months. 12 months No
Secondary Rate of atrial fibrillation through the duration of study follow-up between study arms. 3 years No
Primary The primary objective is to compare the incidence rate of AF through 12 months between the continuous monitoring arm vs control arm in subjects with a recent ischemic stroke of presumed known origin. 12 months
Secondary To compare the incidence rates of AF through the duration of study follow-up between study arms. 3 years

Sponsors