Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (IDENTIFY-HF)
Atrial Fibrillation, Heart Failure
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
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
Sites / Locations
- Scripps Green
- Aurora Denver Cardiology Associates
- Spectrum Health
- The Valley Hospital
- Carolinas Medical Center/Sanger Heart & Vascular
- The Ohio State University
- Lancaster Heart & Stroke Foundation
- Medical University of South Carolina
- St. Thomas Research Institute
- University of Texas Southwestern Medical Center
- Heart Clinic PLLC
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Control arm
Risk Status Guided
Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.
Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).