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This study aims to test the safety and efficacy of lymph fluid drainage on heart congestion and shortness of breath symptoms among patients participants with heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD Drainage | Experimental | Short term TD drainage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD Drainage | Device | Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success for access | Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance | At the time of the procedure |
| Safety defined as the absence of serious adverse events | Safety as measured by number of serious adverse events | Up to 24 hours post-procedure |
| Technical success for drainage | Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter | At the time of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total fluid output (measured in mL) as measured by fluid collection | Total fluid output (measured in mL) as measured by fluid collection | Up to 24 hours post-procedure |
| Change in body weight | Change in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marat Fudim, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marat Fudim | Durham | North Carolina | 27710-0001 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Pre-procedure, Post-procedure (up to 4 hours) |
| Change in blood N-terminal Pro-BNP as measured by lab test | Change in blood N-terminal Pro-BNP as measured by lab test | Baseline, 12 hours, 24 hours post initiation of drainage |
| Number of HF-related hospitalizations as measured by medical record review | Number of HF-related hospitalizations as measured by medical record review | 30 days post-discharge |