Heart Failure Clinical Trial
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Summary
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
Eligibility Criteria
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
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There are 11 Locations for this study
La Jolla California, 92037, United States
Aurora Colorado, 80012, United States
Grand Rapids Michigan, 49503, United States
Ridgewood New Jersey, 07450, United States
Charlotte North Carolina, 28203, United States
Columbus Ohio, 43210, United States
Lancaster Pennsylvania, 17602, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37205, United States
Dallas Texas, 75390, United States
McAllen Texas, 78503, United States
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