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REVEAL AF: Incidence of AF in High Risk Patients

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ClinicalTrials.gov Identifier: NCT01727297
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : March 29, 2018
Last Update Posted : April 30, 2018
Sponsor:
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
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 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 ClinicalTrials.gov identifier (NCT number): NCT01727297


  Show 58 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: James A Reiffel, MD Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov 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