ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
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

November 12, 2012
November 15, 2012
December 13, 2017
March 29, 2018
April 30, 2018
November 13, 2012
January 13, 2017   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01727297 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • 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
Not Provided
Not Provided
 
REVEAL AF: Incidence of AF in High Risk Patients
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Atrial Fibrillation
Device: REVEAL Implantable Cardiac Monitor
REVEAL Implantable Cardiac Monitor
Intervention: Device: REVEAL Implantable Cardiac Monitor
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
446
450
January 30, 2017
January 13, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   Slovenia,   Spain,   United States
 
 
NCT01727297
REVEAL AF
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
Plan to Share IPD: No
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Cardiac Rhythm and Heart Failure
Not Provided
Principal Investigator: James A Reiffel, MD Columbia University
Medtronic Cardiac Rhythm and Heart Failure
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP