Heart Failure
Conditions
Keywords
heart catheterization, heart failure
Brief summary
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.
Interventions
DEVICETD Drainage
Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Subjects with informed consent to participate * NYHA III- IV patients * Patients with heart failure volume overload * Planned for elective right heart catheterization
Exclusion criteria
* Active coronary syndrome (type I myocardial infarction) * Local infection or ongoing systemic infection(s) * Thrombotic coagulation disorder * On continuous blood thinners that cannot be discontinued or held * Allergy or contraindications to the use of iodine-based contrast agents * Subjects deemed to be high risk for performing a cardiac catheterization by study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success for access | At the time of the procedure | Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance |
| Safety defined as the absence of serious adverse events | Up to 24 hours post-procedure | Safety as measured by number of serious adverse events |
| Technical success for drainage | At the time of the procedure | Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total fluid output (measured in mL) as measured by fluid collection | Up to 24 hours post-procedure | Total fluid output (measured in mL) as measured by fluid collection |
| Number of HF-related hospitalizations as measured by medical record review | 30 days post-discharge | Number of HF-related hospitalizations as measured by medical record review |
| Change in body weight | Pre-procedure, Post-procedure (up to 4 hours) | Change in body weight |
| Change in blood N-terminal Pro-BNP as measured by lab test | Baseline, 12 hours, 24 hours post initiation of drainage | Change in blood N-terminal Pro-BNP as measured by lab test |
Countries
United States
Outcome results
None listed