Lymph Drainage in Heart Failure

NCT05240638 | Completed FDA Device

• 1 other identifier: Pro00107814
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart catheterization; heart failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Total fluid output (measured in mL) as measured by fluid collection

  Up to 24 hours post-procedure

• Change in body weight

  Pre-procedure, Post-procedure (up to 4 hours)

• 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

  30 days post-discharge

Study Arms (1)

TD Drainage

EXPERIMENTAL

Short term TD drainage

Device: TD Drainage

Interventions

TD Drainage DEVICE

Image-guided percutaneous cannulation of the TD and drainage with an endovascular catheter (microcatheter)

TD Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Marat Fudim

Durham, North Carolina, 27710-0001, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marat Fudim, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 15, 2022
• Study Start: October 24, 2022
• Primary Completion: May 5, 2023
• Study Completion: July 7, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)