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

Status: Completed
Location: See all (35) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
Cardiovascular Associates of the Southeast
Birmingham
California
Scripps Memorial Hospital La Jolla
La Jolla
University of California San Francisco UCSF Medical Center
San Francisco
Florida
Innovative Medical Research of South Florida
Aventura
University of Miami Hospital
Miami
AdventHealth Neuroscience Institute
Orlando
Hawaii
The Queens Medical Center
Honolulu
Illinois
Northwestern University
Chicago
Kentucky
Baptist Health Lexington
Lexington
Norton Neuroscience Institute
Louisville
Louisiana
Ochsner Medical Center
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
Minnesota
Health Partners Institute (Bloomington MN)
Bloomington
Health Partners Institute (Saint Louis Park MN)
Saint Louis Park
Missouri
Mercy Clinic Cardiology
Saint Louis
Cox Medical Center South
Springfield
North Carolina
Cone Health
Greensboro
New Jersey
Hackensack University Medical Center
Hackensack
New York
Albany Medical Center
Albany
University at Buffalo, The State University of New York
Buffalo
North Shore University Hospital
New Hyde Park
Icahn School of Medicine at Mount Sinai
New York
NYU Langone Medical Center
New York
Overlook Medical Center
Summit
Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
PeaceHealth Sacred Heart Medical Center at Riverbend
Springfield
Pennsylvania
Lancaster General Hospital
Lancaster
Hospital of the University of Pennsylvania
Philadelphia
Lankenau Institute for Medical Research
Wynnewood
Tennessee
Saint Thomas Research Institute
Nashville
Texas
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
Dallas
University of Texas (UT) Southwestern Medical Center
Dallas
Houston Methodist Hospital
Houston
Virginia
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg
Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee
Time Frame
Start Date: 2016-03
Completion Date: 2022-07-28
Participants
Target number of participants: 496
Treatments
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.
No_intervention: Control Arm
Subjects randomized to the control arm will be followed per site specific standard of care.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Rhythm and Heart Failure

This content was sourced from clinicaltrials.gov