Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure

Conditions
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Atrial Fibrillation, Heart Failure

Intervention / Treatment
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* Device: Reveal XT® Insertable Cardiac Monitor
* Other: Heart Failure Risk Status Diagnostic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>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. | Device: Reveal XT® Insertable Cardiac Monitor<br>* If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).<br>* Other names: Reveal XT®;Other: Heart Failure Risk Status Diagnostic<br>* The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High.<br>|
| Experimental: Risk Status Guided<br>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). | Device: Reveal XT® Insertable Cardiac Monitor<br>* If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).<br>* Other names: Reveal XT®;Other: Heart Failure Risk Status Diagnostic<br>* The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of Low, Medium, High, and Very High. The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score. | 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm) |