Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Routine in office visits; Other: Integrated diagnositic system

• Registration Number: NCT01045343
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-03
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Routine in office visits	-
Integrated Diagnostics Arm	Integrated diagnositic system	-

Primary Outcome Measures

Name	Time	Method
Change in subject self-care utilizing the Self-Care of Heart Failure Index	Baseline, 3 months, 6 months, 9 months
Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website)	Baseline to 9 months
Number of clinical actions and types of health care utilizations in which actions are initiated	Baseline to 9 months
Subject outcomes including emergency room (ER) visits, hospitalization and death	Baseline to 9 months
Functional class using measurements including 6-minute hall walk and New York Heart Association class	Hall walk (Baseline to 9 months), NYHA (Baseline, 3 months, 6 months, 9 months)
Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire	Baseline, 3 months, 6 months, 9 months