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Summary

for people ages 50 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

Keywords

Stroke, Acute

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • Scripps Green Hospital accepting new patients
    La Jolla, California, 92037, United States
  • Sacred Heart accepting new patients
    Springfield, Oregon, 97477-8800, United States
  • The University of Oklahoma Health Sciences Center accepting new patients
    Oklahoma City, Oklahoma, 73104, United States
  • Baylor Research Institute accepting new patients
    Dallas, Texas, 75246, United States
  • University of Texas (UT) Southwestern Medical Center accepting new patients
    Dallas, Texas, 75390, United States
  • Cox Medical Center South accepting new patients
    Springfield, Missouri, 65807, United States
  • HealthPartners Institute accepting new patients
    Saint Louis Park, Minnesota, 55426, United States
  • Houston Methodist Hospital accepting new patients
    Houston, Texas, 77030-2703, United States
  • Health Partners Institute accepting new patients
    Bloomington, Minnesota, 55425, United States
  • Mercy Clinic Cardiology accepting new patients
    Saint Louis, Missouri, 63141, United States
  • Aurora Saint Luke's Medical Center accepting new patients
    Milwaukee, Wisconsin, 53215, United States
  • Northwestern University accepting new patients
    Chicago, Illinois, 60611-5928, United States
  • Saint Thomas Research Institute accepting new patients
    Nashville, Tennessee, 37205, United States
  • Norton Neuroscience Institute accepting new patients
    Louisville, Kentucky, 40240, United States
  • Cardiovascular Associates PC accepting new patients
    Birmingham, Alabama, 35243, United States
  • University at Buffalo, The State University of New York accepting new patients
    Buffalo, New York, 14203, United States
  • Cone Health accepting new patients
    Greensboro, North Carolina, 27405, United States
  • Centra Medical Group Stroobants Cardiovascular Center accepting new patients
    Lynchburg, Virginia, 24501, United States
  • Florida Hospital Neuroscience Institute accepting new patients
    Orlando, Florida, 32803, United States
  • Inova Fairfax Hospital not yet accepting patients
    Fairfax, Virginia, 22042, United States
  • Lancaster General Hospital accepting new patients
    Lancaster, Pennsylvania, 17602, United States
  • The Queens Medical Center accepting new patients
    Honolulu, Hawaii, 96813, United States
  • Hospital of the University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Innovative Medical Research accepting new patients
    Aventura, Florida, 33180, United States
  • Overlook Medical Center accepting new patients
    Summit, New York, 07901-3533, United States
  • University of Miami Hospital accepting new patients
    Miami, Florida, 33136, United States
  • Albany Medical Center accepting new patients
    Albany, New York, 12208, United States
  • Hackensack University Medical Center not yet accepting patients
    Hackensack, New Jersey, 07601, United States
  • NYU Langone Medical Center accepting new patients
    New York, New York, 10016-6402, United States
  • Icahn School of Medicine at Mount Sinai accepting new patients
    New York, New York, 10029, United States
  • Northwell Health accepting new patients
    Manhasset, New York, 11030, United States
  • Massachusetts General Hospital accepting new patients
    Boston, Massachusetts, 02114, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT02700945
Lead Scientist
Karl Meisel
Study Type
Interventional
Last Updated
July 1, 2017
I’m interested in this study!