ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02700945
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : March 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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. [ 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. To compare the incidence rates of AF through the duration of study follow-up 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Contacts
Contact: Megan Mueller, BSN 800-633-8766 megan.d.mueller@medtronic.com

  Show 33 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: Richard Bernstein, PhD/MD Northwestern
Principal Investigator: Lee Schwamm, MD Mass General

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02700945     History of Changes
Other Study ID Numbers: Stroke AF
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Vascular Diseases
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes