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REVEAL AF: Incidence of AF in High Risk Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT01727297
First received: November 12, 2012
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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 Intervention
Atrial Fibrillation
Device: REVEAL Implantable cardiac monitor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: REVEAL AF: Incidence of AF in High Risk Patients

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Time to first Atrial Fibrillation lasting six or more minutes. [ Time Frame: Implant to 18 month follow-up visit ]
    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) are at least 6 minutes in duration. The time to the first such episode in which both criteria are met will be the endpoint for each patient.


Secondary Outcome Measures:
  • Predictors of Atrial Fibrillation [ Time Frame: Time from implant to date of last stored available implanted device data (maximum of 30 months) ]
    Atrial Fibrillation 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 atrial fibrillation.

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


Enrollment: 450
Actual Study Start Date: November 13, 2012
Estimated Study Completion Date: April 28, 2017
Primary Completion Date: January 13, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
REVEAL Implantable cardiac monitor Device: REVEAL Implantable cardiac monitor

  Eligibility

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

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 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 IPG, ICD, CRT-P, or CRT-D device
  • NYHA Class IV Heart Failure patient
  • Patient had heart surgery within previous 90 days prior to enrollment
  • Patient had an 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727297

  Hide Study Locations
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
St. Petersburgh, 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
Austria
LKH - Universitätsklinikum Graz
Graz, Austria, 8036
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz, Austria, 4010
Germany
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
Italy
Azienda Ospedaliera San Gerardo
Monza, Italy, 20090
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
Nergrar, Italy, 37024
Ospedale civile di Ciriè
Torino, Italy, 10073
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43007
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: James A Reiffel, MD Columbia University
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01727297     History of Changes
Other Study ID Numbers: REVEAL AF
Study First Received: November 12, 2012
Last Updated: February 21, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017