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

Not Applicable

Completed

Conditions: Stroke, Acute

Interventions: Device: Reveal LINQ™ Insertable Cardiac Monitor

Registration Number: NCT02700945

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 496

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reveal LINQ™ Insertable Cardiac Monitor	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.

Primary Outcome Measures

Name	Time	Method
The Rate of AF Through 12 Months in Subjects With a Recent Ischemic Stroke of Presumed Known Origin.	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

Name	Time	Method
The Rate of AF Through the Duration of Study Follow-up (36 Months) Between Study Arms.	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.

Trial Locations

Locations (35): Innovative Medical Research of South Florida
🇺🇸
Aventura, Florida, United States
Health Partners Institute (Saint Louis Park MN)
🇺🇸
Saint Louis Park, Minnesota, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Cox Medical Center South
🇺🇸
Springfield, Missouri, United States
University at Buffalo, The State University of New York
🇺🇸
Buffalo, New York, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Cardiovascular Associates of the Southeast
🇺🇸
Birmingham, Alabama, United States
University of California San Francisco UCSF Medical Center
🇺🇸
San Francisco, California, United States
University of Miami Hospital
🇺🇸
Miami, Florida, United States
Saint Thomas Research Institute
🇺🇸
Nashville, Tennessee, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
Aurora Saint Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
The University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Scripps Memorial Hospital La Jolla
🇺🇸
La Jolla, California, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
AdventHealth Neuroscience Institute
🇺🇸
Orlando, Florida, United States
The Queens Medical Center
🇺🇸
Honolulu, Hawaii, United States
Norton Neuroscience Institute
🇺🇸
Louisville, Kentucky, United States
Health Partners Institute (Bloomington MN)
🇺🇸
Bloomington, Minnesota, United States
Mercy Clinic Cardiology
🇺🇸
Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
North Shore University Hospital
🇺🇸
New Hyde Park, New York, United States
Overlook Medical Center
🇺🇸
Summit, New York, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Cone Health
🇺🇸
Greensboro, North Carolina, United States
PeaceHealth Sacred Heart Medical Center at Riverbend
🇺🇸
Springfield, Oregon, United States
Lankenau Institute for Medical Research
🇺🇸
Wynnewood, Pennsylvania, United States
University of Texas (UT) Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Baylor Research Institute Dallas - Baylor University Medical Center (BUMC)
🇺🇸
Dallas, Texas, United States
Centra Medical Group Stroobants Cardiovascular Center
🇺🇸
Lynchburg, Virginia, United States