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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700945
Recruitment Status : Completed
First Posted : March 7, 2016
Results First Posted : November 9, 2021
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: Reveal LINQ™ Insertable Cardiac Monitor Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 3, 2020
Actual Study Completion Date : July 28, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Reveal LINQ™ Insertable Cardiac Monitor
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
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.
Other Names:
  • LINQ
  • LINQ™
No Intervention: Control Arm
Subjects randomized to the control arm will be followed per site specific standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms. [ Time Frame: 3 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700945


Locations
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Chair: Richard Bernstein, PhD/MD Northwestern
Study Chair: Lee Schwamm, MD Mass General
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
Study Protocol  [PDF] December 18, 2018
Statistical Analysis Plan  [PDF] May 15, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02700945    
Other Study ID Numbers: Stroke AF
First Posted: March 7, 2016    Key Record Dates
Results First Posted: November 9, 2021
Last Update Posted: May 26, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This data is for internal, Medtronic use only. Data from the study will be analyzed and submitted in the form of abstracts and possible publication in a journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes