REVEAL AF: Incidence of AF in High Risk Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727297
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : March 29, 2018
Last Update Posted : April 30, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: REVEAL Implantable Cardiac Monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: REVEAL AF: Incidence of AF in High Risk Patients
Actual Study Start Date : November 13, 2012
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
REVEAL Implantable Cardiac Monitor Device: REVEAL Implantable Cardiac Monitor

Primary Outcome Measures :
  1. 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes [ Time Frame: Implant to 18 months post device insertion ]
    Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.

Secondary Outcome Measures :
  1. Predictors of the Incidence of AF [ Time Frame: Time from implant to date of last stored available device data (maximum of 30 months) ]
    AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.

  2. Actions Taken in Response to Awareness of AF [ Time Frame: Time from first identified episode of AF to study exit (maximum of 30 months) ]
    Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727297

  Hide Study Locations
United States, Arizona
Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306-1870
United States, California
Cardiovascular Consultants Heart Center
Fresno, California, United States, 93720-3235
Desert Heart Rhythm Consultants
Palm Springs, California, United States, 92262
Healdsburg Cardiology
Windsor, California, United States, 95492
United States, Delaware
Nanticoke Cardiology
Seaford, Delaware, United States, 19973
United States, Florida
Bradenton Cardiology
Bradenton, Florida, United States, 34205-8805
The Cardiac & Vascular Institute
Gainesville, Florida, United States, 32605-4218
Cardiac Clinic
Kissimmee, Florida, United States, 34741
Northside Hospital
Saint Petersburg, Florida, United States, 33709
United States, Georgia
North Georgia Heart Foundation
Gainesville, Georgia, United States, 30501-3427
United States, Indiana
Premier HealthCare
Bloomington, Indiana, United States, 47403-3239
Cardiovascular Consultants PC (Munster IN)
Munster, Indiana, United States, 46321-4054
United States, Kansas
The University Kansas Medical Center Research Institute Inc
Kansas City, Kansas, United States, 66160-8500
Cardiovascular Consultants of Kansas
Wichita, Kansas, United States, 67226
United States, Maryland
Delmarva Heart Research Foundation Inc
Salisbury, Maryland, United States, 21804-6951
United States, Minnesota
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407-1195
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417-2309
United States, Mississippi
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216-4634
United States, Missouri
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110-2539
Cox Medical Center South
Springfield, Missouri, United States, 65807-5251
United States, Montana
Glacier View Research Institute Cardiology
Kalispell, Montana, United States, 59901
United States, Nebraska
CHI Health Cardiology (Bergen)
Omaha, Nebraska, United States, 68124-2319
United States, New Jersey
Englewood Hospital & Medical Center
Englewood, New Jersey, United States, 07631-1808
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Valley Hospital
Ridgewood, New Jersey, United States, 07450-2726
Lourdes Cardiology Services
Voorhees, New Jersey, United States, 08043
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032-3725
United States, North Carolina
Caromont Regional Medical Center
Gastonia, North Carolina, United States, 28054-2140
United States, Ohio
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, United States, 44504-1006
United States, Oklahoma
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Salem Cardiovascular Associates
Salem, Oregon, United States, 97302
United States, Pennsylvania
The Heart Care Group PC (Allentown PA)
Allentown, Pennsylvania, United States, 18103-6202
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096-3450
United States, Rhode Island
South County Cardiology
Wakefield, Rhode Island, United States, 02879-4253
United States, Tennessee
Selcuk A. Tombul, D.O., F.A.C.C.
Chattanooga, Tennessee, United States, 37404
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138-1727
Sutherland Cardiology Clinic
Germantown, Tennessee, United States, 38138-1760
Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
United States, Texas
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226-1301
Baylor Research Institute (Plano TX)
Plano, Texas, United States, 75093-3691
Woodlands North Houston Heart and Vein Center
The Woodlands, Texas, United States, 77384-4167
United States, Wisconsin
ProHealth Care
Waukesha, Wisconsin, United States, 53188
LKH - Universitätsklinikum Graz
Graz, Austria, 8036
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz, Austria, 4010
Klinikum Coburg GmbH
Coburg, Germany, 96450
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Universitätsmedizin Göttingen Georg-August-Universität
Gottingen, Germany, 37075
Asklepios Klinik Sankt Georg
Hamburg, Germany, 20099
Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un
Lünen, Germany, 44534
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Azienda Ospedaliera San Gerardo
Monza, Italy, 20090
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
Negrar, Italy, 37024
Ospedale civile di Ciriè
Torino, Italy, 10073
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43007
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Principal Investigator: James A Reiffel, MD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT01727297     History of Changes
Other Study ID Numbers: REVEAL AF
First Posted: November 15, 2012    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: April 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes