Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
446 participants
INTERVENTIONAL
2012-11-13
2017-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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REVEAL Implantable Cardiac Monitor
REVEAL Implantable Cardiac Monitor
Interventions
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REVEAL Implantable Cardiac Monitor
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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James A Reiffel, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Phoenix Heart, PLLC
Glendale, Arizona, United States
Cardiovascular Consultants Heart Center
Fresno, California, United States
Desert Heart Rhythm Consultants
Palm Springs, California, United States
Healdsburg Cardiology
Windsor, California, United States
Nanticoke Cardiology
Seaford, Delaware, United States
Bradenton Cardiology
Bradenton, Florida, United States
The Cardiac & Vascular Institute
Gainesville, Florida, United States
Cardiac Clinic
Kissimmee, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
North Georgia Heart Foundation
Gainesville, Georgia, United States
Premier HealthCare
Bloomington, Indiana, United States
Cardiovascular Consultants PC (Munster IN)
Munster, Indiana, United States
The University Kansas Medical Center Research Institute Inc
Kansas City, Kansas, United States
Cardiovascular Consultants of Kansas
Wichita, Kansas, United States
Delmarva Heart Research Foundation Inc
Salisbury, Maryland, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Cox Medical Center South
Springfield, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Glacier View Research Institute Cardiology
Kalispell, Montana, United States
CHI Health Cardiology (Bergen)
Omaha, Nebraska, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
Caromont Regional Medical Center
Gastonia, North Carolina, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
Salem Cardiovascular Associates
Salem, Oregon, United States
The Heart Care Group PC (Allentown PA)
Allentown, Pennsylvania, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
South County Cardiology
Wakefield, Rhode Island, United States
Selcuk A. Tombul, D.O., F.A.C.C.
Chattanooga, Tennessee, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Sutherland Cardiology Clinic
Germantown, Tennessee, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Baylor Research Institute (Plano TX)
Plano, Texas, United States
Woodlands North Houston Heart and Vein Center
The Woodlands, Texas, United States
ProHealth Care
Waukesha, Wisconsin, United States
LKH - Universitätsklinikum Graz
Graz, , Austria
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz, , Austria
Klinikum Coburg GmbH
Coburg, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, , Germany
Asklepios Klinik Sankt Georg
Hamburg, , Germany
Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un
Lünen, , Germany
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, , Germany
Azienda Ospedaliera San Gerardo
Monza, , Italy
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
Negrar, , Italy
Ospedale civile di Ciriè
Torino, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Hospital Universitari de Tarragona Joan XXIII
Tarragona, , Spain
Countries
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References
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Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.
Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
Other Identifiers
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REVEAL AF
Identifier Type: -
Identifier Source: org_study_id
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