REVEAL AF: Incidence of AF in High Risk Patients

Study Overview
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Brief Summary
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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.

Official Title
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REVEAL AF: Incidence of AF in High Risk Patients

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: REVEAL Implantable Cardiac Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: REVEAL Implantable Cardiac Monitor<br> | Device: REVEAL Implantable Cardiac Monitor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes | 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. | Implant to 18 months post device insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of the Incidence of AF | 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. | Time from implant to date of last stored available device data (maximum of 30 months) | 
| Actions Taken in Response to Awareness of AF | Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized | Time from first identified episode of AF to study exit (maximum of 30 months) |