Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure (INDICATE HF)

Medtronic

Status

Completed

Conditions

Heart Failure

Treatments

Other: Routine in office visits

Other: Integrated diagnositic system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01045343

INDICATE HF

Details and patient eligibility

About

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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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