Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. This system consists of patient tools, a new heart failure risk score and a new clinician website. This study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.

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Detailed Description

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Conditions

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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

Group Type ACTIVE_COMPARATOR

Routine in office visits

Intervention Type OTHER

Heart failure will be managed with scheduled in-office visits every three months.

Integrated Diagnostics Arm

Group Type EXPERIMENTAL

Integrated diagnositic system

Intervention Type OTHER

Heart failure will be managed using the integrated diagnostic system which consists of patient tools and a new Heart Failure Clinician's website which displays a new Heart Failure Risk score. This Heart Failure Clinician's website will be reviewed every 2 weeks in addition to scheduled in-office visits every three months.

Interventions

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Integrated diagnositic system

Heart failure will be managed using the integrated diagnostic system which consists of patient tools and a new Heart Failure Clinician's website which displays a new Heart Failure Risk score. This Heart Failure Clinician's website will be reviewed every 2 weeks in addition to scheduled in-office visits every three months.

Intervention Type OTHER

Routine in office visits

Heart failure will be managed with scheduled in-office visits every three months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is willing and able to provide written informed consent
* Subject is at least 18 years of age
* Subject is willing and able to comply with the Clinical Investigation Plan
* Subject is currently enrolled in the Medtronic CareLink® Network
* Subject is currently a New Heart Association (NYHA) functional class III or NYHA functional class II with a heart failure related hospitalization within the past 180 days
* Subject has a Medtronic Concerto®/Consulta® cardiac resynchronization therapy (CRT)device implanted for at least 180 days
* Subject has been prescribed daily oral diuretic therapy for the management of heart failure

Exclusion Criteria

* Subject is enrolled in a concurrent study with the exception of a study approved by the INDICATE HF Clinical Trial Leader
* Subject has a life expectancy of less than 1 year
* Subject's CRT device has an estimated battery life of less than 2 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No