Heart Failure
Conditions
Keywords
heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)
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.
Interventions
OTHERRoutine in office visits
Heart failure will be managed with scheduled in-office visits every three months.
OTHERIntegrated 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed