Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control arm

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.

Group Type OTHER

Reveal XT® Insertable Cardiac Monitor

Intervention Type DEVICE

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).

Heart Failure Risk Status Diagnostic

Intervention Type OTHER

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".

Risk Status Guided

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).

Group Type EXPERIMENTAL

Reveal XT® Insertable Cardiac Monitor

Intervention Type DEVICE

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).

Heart Failure Risk Status Diagnostic

Intervention Type OTHER

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".

Interventions

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Reveal XT® Insertable Cardiac Monitor

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).

Intervention Type DEVICE

Heart Failure Risk Status Diagnostic

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".

Intervention Type OTHER

Other Intervention Names

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Reveal XT®

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No