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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HL145941 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Cleveland Clinic Florida | OTHER |
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Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.
The overall objective of research is to test, adapt, refine and validate the HEMOTAG® system to be used outside the usual medical care environments to reduce hospital readmissions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Standard of Care | No Intervention | Standard of Care | |
| Randomized Standard of Care with HEMOTAG | Active Comparator | Standard of Care with HEMOTAG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care with Hemotag | Diagnostic Test | Comparison of outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of recurrent HF readmissions. [Monitoring period: 30 days] | Determine if HEMOTAG can reduce the relative number of HF readmissions or ER visits versus standard of care. [Monitoring period: 30 days from time of participant's discharge from initial index hospitalization] | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Time from discharge until the first event of HF readmissions [Monitoring period: Event time assessed up to 3 months and 6 months from discharge. | Time from discharge to the first event of HF readmissions or ER visits [Monitoring period: Event time assessed up to 3 months and 6 months from time of participant's discharge from initial study hospitalization.] | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cindy Kober | Contact | 561-945-9303 | cindy@aventusoft.com | |
| Kaustubh Kale | Contact | 954-399-3335 | kaustubh@aventusoft.com |
| Name | Affiliation | Role |
|---|---|---|
| David Snipelisky, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Number of total days lost to hospitalization due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months] | Total number of total days lost to hospitalization or ER visit due to HF events [Monitoring period: Expected average of 30 days, 3 months, 6 months from time of participant's discharge from index hospitalization.] | 6 Months |
| Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months] | Time from discharge to all-cause mortality [Monitoring period: 30 days, 3 months,6 months from time of participant's discharge from initial study hospitalization.] | 6 Months |
| Skin irritation from HEMOTAG use [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use.) | Incidence of skin irritation [Time Frame: over the measurement period of 30 days] (Determine if subjects had skin irritation from use of device.) | 30 Days |
| Baylor Scott & White Research Institute | Recruiting | Temple | Texas | 76508 | United States |
|