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

Not Applicable

Completed

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

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

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.

Locations (35): Cardiovascular Associates of the Southeast
🇺🇸
Birmingham, Alabama, United States
Scripps Memorial Hospital La Jolla
🇺🇸
La Jolla, California, United States
University of California San Francisco UCSF Medical Center
🇺🇸
San Francisco, California, United States
Innovative Medical Research of South Florida
🇺🇸
Aventura, Florida, United States
University of Miami Hospital
🇺🇸
Miami, Florida, United States
AdventHealth Neuroscience Institute
🇺🇸
Orlando, Florida, United States
The Queens Medical Center
🇺🇸
Honolulu, Hawaii, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Norton Neuroscience Institute
🇺🇸
Louisville, Kentucky, United States
Scroll for more (25 remaining)
Cardiovascular Associates of the Southeast
🇺🇸Birmingham, Alabama, United States