Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Inclusion criteria

• Patient is 18 years of age or older
• Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
• Patient is willing and able to comply with the protocol, including follow-up visits
• Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
• Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor
• Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home
• Willing and able to transmit data via CareLink

Exclusion criteria

• Patient is pregnant
• Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures
• Endstage (Stage D or New York Heart Association class IV) heart failure
• Asymptomatic (Stage B or New York Heart Association class I) heart failure
• Severe aortic stenosis or insufficiency
• Existing insertable cardiac monitor implanted for more than 1 year
• Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
• Severe renal impairment (estimated glomerular filtration rate <25mL/min)
• Myocardial infarction within prior 30 days