Stoke AF

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Trial ID:: IRB-17-6932; Mary Kalafut

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.

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

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.