Lymph Drainage in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: TD Drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD Drainage<br>Short term TD drainage | Device: TD Drainage<br>* Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart catheterization, heart failure