Post-Embolic Rhythm Detection With Implantable Versus External Monitoring "PERDIEM"

Recruiting

Phase N/A Results N/A

Trial Description

The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke.
A summary of the rationale for this study is as follows:
1. Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke.
2. The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed.
3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes.
4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data
5. The rates of PAF in strokes with known causes (SKC) have not been well characterized.
PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted.
The principal research questions to be addressed in this study will be:
1. What is the relative cost-effectiveness as a first line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke.
2. What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.

Conditions

Interventions

  • Medtronic Reveal LINQ Device
    ARM 1: Kind: Experimental
    Label: Implanted Loop Recorder
    Description: long-term implantable ECG (Medtronic Reveal LINQ) coupled with remote monitoring (MyCareLink) for 12 months
  • Sorin Spiderflash-t Device
    ARM 1: Kind: Experimental
    Label: External Loop Recorder
    Description: external event-triggered ECG loop recorder (Sorin Spiderflash-t) for 30 days

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Cost-effectiveness 12 months No
Secondary Detection of atrial arrhythmia (AF / atrial flutter) that results in initiation of additional anti-platelet or oral anticoagulant therapy as per usual clinical practice. 12, 24, 36 months No
Secondary Compliance with assigned therapy (accept ILR, conduct at least 80% of ELR assessments) 30 days, 12 months No
Secondary Costs for all cardiac and non-cardiac investigations related to etiologic workup of index stroke / TIA. 12 months No
Secondary Total duration of any detected atrial fibrillation / atrial flutter. 30 days, 6 months, 12, 24, 36 months No
Secondary Study related adverse events / serious adverse events. 30 days, 6, 12, 24, 36 months Yes
Secondary Clinical recurrence of ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death. 30 days, 6, 12, 24, 36 months No

Sponsors