REVEAL AF: Incidence of AF in High Risk Patients

Medtronic

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: REVEAL Implantable Cardiac Monitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01727297

REVEAL AF

Details and patient eligibility

About

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.

Enrollment

446 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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