REVEAL AF: Incidence of AF in High Risk Patients

This is an interventional screening trial for Atrial Fibrillation Read More

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