Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01045343

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

136

Starts

2010-03-01

Expected to finish

2012-02-01

Last updated by the study team

2012-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Aurora, Colorado, United States
• Study site — Tampa, Florida, United States
• Study site — Louisville, Kentucky, United States
• Study site — Jackson, Mississippi, United States
• Study site — Omaha, Nebraska, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Abington, Pennsylvania, United States
• Study site — Doylestown, Pennsylvania, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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