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

April 28, 2023 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Cardiovascular Associates of the Southeast
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital La Jolla
      • San Francisco, California, United States, 94143
        • University of California San Francisco UCSF Medical Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Innovative Medical Research of South Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Neuroscience Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queens Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • Norton Neuroscience Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70201
        • Ochsner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Bloomington, Minnesota, United States, 55101
        • Health Partners Institute (Bloomington MN)
      • Saint Louis Park, Minnesota, United States, 55426
        • Health Partners Institute (Saint Louis Park MN)
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Clinic Cardiology
      • Springfield, Missouri, United States, 65807
        • Cox Medical Center South
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Albany, New York, United States, 12211
        • Albany Medical Center
      • Buffalo, New York, United States, 14203
        • University at Buffalo, The State University of New York
      • New Hyde Park, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • Summit, New York, United States, 07901
        • Overlook Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Cone Health
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center
    • Oregon
      • Springfield, Oregon, United States, 97477
        • PeaceHealth Sacred Heart Medical Center at Riverbend
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of The University of Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
      • Dallas, Texas, United States, 75390
        • University of Texas (UT) Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Centra Medical Group Stroobants Cardiovascular Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Richard Bernstein, PhD/MD, Northwestern
  • Study Chair: Lee Schwamm, MD, Mass General

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Stroke AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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