Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02428140
• Date of registration: 23/04/2015
• Prospective Registration: Yes
• Primary sponsor: University of Alberta
• Public title: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring PERDIEM
• Scientific title: Post-Embolic Rhythm Detection With Implantable Versus External Monitoring: Pilot and Feasibility Study
• Date of first enrolment: July 2015
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02428140
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Brian H Buck, MD, MSc
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke
or TIA occurring within the previous 90 days. The event must be either:

1. an arterial ischemic stroke confirmed by neuroimaging; or

2. transient ischemic attack with diffusion weighted positive lesion on MRI

- At least one 12-lead ECG has already been obtained as part of the routine clinical
post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or
atrial flutter

- The patient is being actively investigated for the etiology of the stroke/TIA event
and additional cardiac monitoring is desired to screen further for the possibility of
occult paroxysmal atrial fibrillation/flutter

- Age 18 years or older

- Informed consent from the patient

- The patient is expected to survive at least 6 months.

Exclusion Criteria:

- Any previously documented atrial fibrillation or atrial flutter, i.e. a past history
of atrial fibrillation/flutter or atrial fibrillation/flutter detected on ECG, Holter,
or telemetry following the index stroke/TIA event (a remote history of transient
perioperative atrial fibrillation is not exclusionary)

- Planned carotid endarterectomy or carotid artery stenting within 90 days

- Any condition for which there is already an indication for long term anticoagulation
Pacemaker or implantable cardioverter defibrillator device

- Work-up for stroke that has already included extended (>48 hour) external ECG
(excluding telemetry)

- Stroke and/or comorbid illness will prevent completion of planned follow-up
assessments



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Atrial Fibrillation

Arrhythmias, Cardiac

Intervention(s)

Device: Medtronic Reveal LINQ

Device: Sorin Spiderflash-t

Primary Outcome(s)

Detection of clinically actionable AF [Time Frame: 12 months]

Secondary Outcome(s)

Costs of cardiac and non-cardiac investigations [Time Frame: 12, 24, 36 months]

Clinical silent strokes, microbleeds, white matter disease [Time Frame: 12, 24 months]

Detection of clinically actionable AF or death [Time Frame: 12, 24, 36 months]

Duration of any detected atrial fibrillation / atrial flutter. [Time Frame: 30 days, 6 months, 12, 24, 36 months]

Ischemic stroke / TIA, death, hemorrhagic stroke, major adverse bleeding, or death. [Time Frame: 30 days, 6, 12, 24, 36 months]

Compliance [Time Frame: 30 days, 12 months]

Study related adverse events / serious adverse events. [Time Frame: 30 days, 6, 12, 24, 36 months]

Secondary ID(s)

00051629

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alberta Innovates Health Solutions

Medtronic

University of Calgary