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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: Reveal LINQ™ Insertable Cardiac Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had an ischemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days Subject is willing and able to undergo study requirements and expected to be geographically stable during study follow-up Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke: Congestive heart failure Hypertension (Systolic Blood Pressure > 140) Diabetes Mellitus Prior Stroke (>90 days ago, other than study qualifying index event) Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque) Exclusion Criteria: Subject has had a cryptogenic stroke Subject has had a cardioembolic stroke Subject has untreated hyperthyroidism Subject has had a recent myocardial infarction <1 month of stroke Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke Subject has a mechanical heart valve Subject has valvular disease requiring immediate surgical intervention Subject has documented prior history of atrial fibrillation or atrial flutter Subject has permanent indication for oral anticoagulation Subject has permanent contraindication to oral anticoagulation such that detection of AF would not change medical management, based on enrolling investigators judgment Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment in any concurrent clinical study (including registries) requires approval of the study manager or designee. Subject's life expectancy is less than 1 year Subject is pregnant Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable hemodynamic monitor Subject with a medical condition that precludes the patient from participation in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized 1:1 to the continuous monitoring arm or the control arm. Subjects randomized to the continuous monitoring arm will have a Reveal LINQ ICM 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reveal LINQ™ Insertable Cardiac Monitor<br>Subjects randomized to the Reveal LINQ™ Insertable Cardiac Monitor arm will be continuously monitored via the inserted Reveal LINQ™ device. | Device: Reveal LINQ™ Insertable Cardiac Monitor<br>* 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.<br>* Other names: LINQ™;|
| No Intervention: Control Arm<br>Subjects randomized to the control arm will be followed per site specific standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. | AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. | AF will be defined as an AF event lasting more than 30 seconds. The first AF episode detected and adjudicated by the endpoint adjudication committee will be used for this analysis. | 3 years |