REVEAL AF: Incidence of AF in High Risk Patients

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: REVEAL Implantable Cardiac Monitor

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REVEAL Implantable Cardiac Monitor	Device: REVEAL Implantable Cardiac Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes	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.	Implant to 18 months post device insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of the Incidence of AF	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.	Time from implant to date of last stored available device data (maximum of 30 months)
Actions Taken in Response to Awareness of AF	Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized	Time from first identified episode of AF to study exit (maximum of 30 months)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: James A Reiffel, MD, Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2012
• Primary Completion (Actual): January 13, 2017
• Study Completion (Actual): January 30, 2017

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: REVEAL AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No