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REVEAL AF: Incidence of AF in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01727297
First received: November 12, 2012
Last updated: December 3, 2013
Last verified: December 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Reveal XT Implantable Cardiac Monitor

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Time to first Atrial Fibrillation lasting six or more minutes. [ Time Frame: Implant to 18 month follow-up visit ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Clinical actions taken in response to clinician awareness of a patient's atrial fibrillation onset or progression will be summarized


Estimated Enrollment: 450
Study Start Date: October 2012
Estimated Primary Completion Date: August 2016 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: REVEAL AF Study Team Medtroniccrmtrials@medtronic.com

  Show 34 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01727297     History of Changes
Other Study ID Numbers: REVEAL AF
Study First Received: November 12, 2012
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Netherlands: Medical Ethics Review Committee (METC)
Slovenia: Ethics Committee

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

ClinicalTrials.gov processed this record on November 20, 2014