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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator |
| |
| Integrated Diagnostics Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated diagnositic system | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| INDICATE HF Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | United States | ||||
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|
| Routine in office visits | Other | Heart failure will be managed with scheduled in-office visits every three months. |
|
| Aurora |
| Colorado |
| United States |
| Tampa | Florida | United States |
| Louisville | Kentucky | United States |
| Jackson | Mississippi | United States |
| Omaha | Nebraska | United States |
| Voorhees Township | New Jersey | United States |
| Cincinnati | Ohio | United States |
| Abington | Pennsylvania | United States |
| Doylestown | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Burlington | Vermont | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009819 | Office Visits |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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