REVEAL AF: Incidence of AF in High Risk Patients



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/2/2018
Start Date:November 13, 2012
End Date:January 30, 2017

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This study is to determine, through continuous monitoring with the Reveal implantable cardiac
monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high
risk for having AF and to understand how physicians manage these patients after AF has been
detected. This study will also seek to identify what patient characteristics are most
predictive of developing AF.


Inclusion Criteria:

- Patient meets the approved indications to receive the Reveal ICM

- Patient is suspected, based on symptomatology and/or demographics, of having atrial
fibrillation or at high risk of having AF, as determined by the clinical investigator

- Patient has a Congestive heart failure, Hypertension, Age ≥75 years, Diabetes
mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled)
(CHADS2) score ≥ 3 OR has a CHADS2 score = 2 with at least one of the following
documented: renal impairment (GFR 30-60 ml/min), sleep apnea, coronary artery disease,
or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the
CHADS2 score for this trial is limited to either an ischemic stroke or TIA, which
occurred more than one year prior to enrollment.

- Patient is 18 years of age or older

- Patient has a life expectancy of 18 months or more

- Patient, or legally authorized representative, is willing to sign and date the consent
form

- Patient is willing and able to be remotely monitored (i.e., eligible for enrollment
into the Medtronic CareLink Network)

Exclusion Criteria:

- Patient has a documented history of AF or atrial flutter

- Patient had an ischemic stroke or TIA within past year prior to enrollment

- Patient has a history of a hemorrhagic stroke

- Patient is currently implanted with an implantable pulse generator (IPG), implantable
cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P),
or cardiac resynchronization therapy defibrillator (CRT-D) device

- New York Heart Association (NYHA) Class IV Heart Failure patient

- Patient had heart surgery within previous 90 days prior to enrollment

- Patient had a myocardial infarction (MI) within the previous 90 days prior to
enrollment

- Patient is taking chronic immuno-suppressant therapy

- Patient is taking an anti-arrhythmic drug

- Patient is contraindicated for long term anticoagulation medication

- Patient is taking a long-term anticoagulation medication

- Any concomitant condition which, in the opinion of the investigator, would not allow
safe participation in the study (e.g., drug addiction, alcohol abuse, emotional /
psychological diagnosis)

- Patient is enrolled in another study that could confound the results of this study,
without documented pre-approval from Medtronic study manager

- Patient has a creatinine clearance <30 ml/min or is on dialysis
We found this trial at
44
sites
1249 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
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Bloomington, Indiana 47403
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Bradenton, Florida 34205
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2341 McCallie Avenue
Chattanooga, Tennessee 37404
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Dallas, TX
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Fresno, California 93720
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Gainesville, Florida 32605
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Gainesville, Georgia 30501
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Gastonia, North Carolina 28054
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Germantown, Tennessee 38138
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Germantown, Tennessee 38138
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Glendale, Arizona 85306
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1 Auenbruggerplatz
Graz, 8036
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Graz,
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Jackson, Mississippi 39216
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Kalispell, MT
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311 West Oak Street
Kissimmee, Florida 34741
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Knoxville, Tennessee 37934
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Minneapolis, Minnesota 55407
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Minneapolis, Minnesota 55417
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10010 Powers Drive
Munster, Indiana 46321
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Oklahoma City, Oklahoma 73120
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7500 Mercy Road
Omaha, Nebraska 68124
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1100 North Palm Canyon Drive
Palm Springs, California 92262
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1100 Allied Drive
Plano, Texas 75093
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33709
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885 Mission Street Southeast
Salem, Oregon 97302
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Salisbury, Maryland 21804
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200 Federal Street
Seaford, Delaware 19973
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3801 South National Avenue
Springfield, Missouri 65807
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Voorhees, New Jersey 08043
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70 Kenyon Avenue
Wakefield, Rhode Island 02879
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Waukesha, Wisconsin 53188
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9350 East 35th Street North
Wichita, Kansas 67226
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421 March Avenue
Windsor, California 95492
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Wynnewood, Pennsylvania 19096
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1044 Belmont Avenue
Youngstown, Ohio 44504
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