REVEAL AF: Incidence of AF in High Risk Patients

Medtronic Cardiac Rhythm and Heart Failure58 sites in 3 countries446 target enrollmentNovember 13, 2012

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 446
Locations: 58
Primary Endpoint: 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2012

End Date

January 30, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

Predictors of the Incidence of AF(Time from implant to date of last stored available device data (maximum of 30 months))
Actions Taken in Response to Awareness of AF(Time from first identified episode of AF to study exit (maximum of 30 months))