Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (IDENTIFY-HF)

Medtronic

Status: Completed

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Other: Heart Failure Risk Status Diagnostic; Device: Reveal XT® Insertable Cardiac Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486316

IDENTIFY-HF

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Control arm

Other group

Description:

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.

Treatment:

Other: Heart Failure Risk Status Diagnostic

Device: Reveal XT® Insertable Cardiac Monitor

Risk Status Guided

Experimental group

Description:

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).

Treatment:

Other: Heart Failure Risk Status Diagnostic

Device: Reveal XT® Insertable Cardiac Monitor