Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.
Study Start Date
Estimated Completion Date
- Device: Reveal LINQ Insertable Cardiac Monitor
- Cardiology: Arrhythmias/EP,Vascular Medicine
- Physician Assistant: Cardiology
- Atrial Fibrillation
- Atrial Fibrillation
- Cerebral Infarction
North Shore Long Island Jewish Health System -- 14-336
North Shore Long Island Jewish Health System
- Patients with a recent ischemic stroke or transient ischemic attack (TIA) with brain infarction on brain imaging.
- No history of atrial fibrillation or finding of atrial fibrillation on standard inpatient monitoring (electrocardiogram, telemetry, 24-hour Holter monitor)
- Have a presumed stroke etiology: Lacunar or small vessel thrombosis, extra-cranial or intracranial atherosclerotic stenosis or dissection, arteriopathy or vasculitis, hypercoagulable state, aortic arch plaque with or without mobile elements, or evidence of a low-risk cardiac source (e.g., patent foramen ovale with or without atrial septal aneurysm and with or without evidence of venous thromboembolic source).
- Have virtual CHADS2 score ?3 or
- Have 2 or more of the following co-morbidities: obstructive sleep apnea, coronary artery disease, (Chronic Pulmonary Obstructive Disease (COPD), hyperthyroidism, Body Mass Index> 30, prior myocardial infarction, prolonged PR interval (>175 ms) or renal impairment (GFR 30-60).
- Patient or legally authorized representative who is willing to sign written consent form.
- Patient is ?40 years old (patients younger than 40 years old have a very low likelihood of having atrial fibrillation and are therefore excluded from the study).
- Patient can have the device implanted within 7 days of the incident ischemic event
- Documented history of AF or atrial flutter.
- Evidence of a high-risk cardiac source of embolism (Left Ventricular or Left Atrial thrombus or "smoke," emboligenic valvular lesion or tumor)
- Untreated hyperthyroidism.
- Myocardial infarction or coronary bypass grafting within 1 month prior to the stroke/TIA.
- Valvular disease requiring immediate surgical intervention.
- Permanent indication for anticoagulation at enrollment.
- Permanent oral anticoagulation contraindication.
- Already included in another clinical trial that will affect the objectives of this study.
- Life expectancy is less than 1 year.
- Pregnancy. Urine or serum pregnancy test is required for women of child bearing potential to exclude pregnancy.
- Patient is indicated for implant with a pacemaker, implantable cardioverter-defibrillator, CRT device, or an implantable hemodynamic monitoring system
- Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan.
- Cryptogenic Stroke: A stroke/TIA will be considered cryptogenic if no cause is determined despite extensive inpatient workup according to the standard diagnostic protocol at North Shore University Hospital.
41 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|North Shore University Hospital - Manhasset, New York||46.8 miles||None||None||None|