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The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reprieve System | Experimental | Subjects will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reprieve System | Device | The study is broken into stages:
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Device Success | Defined as the device's ability to perform its intended function as specified in the study protocol without any device-related adverse events or malfunctions as determined by the treating physician. | Over the 72-hours maximum duration of therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tony Fields | Contact | +1-650-224-3884 | tfields@reprievecardio.com |
| Name | Affiliation | Role |
|---|---|---|
| Tamaz Shaburishvili, MD | Tbilisi Heart and Vascular Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart and Vascular Clinic | Recruiting | Tbilisi | 0159 | Georgia |
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