REVEAL AF: Incidence of AF in High Risk Patients

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