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FLOWS-HF : Feasibility of Lymphatic Offloading with Stenting in Heart Failure

NCT06554912 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-27

No results posted yet for this study

Summary

The main objective is to evaluate the safety of lymphatic decompression in heart failure.

The research hypothesis is that lymphatic decompression is safe and feasible in heart failure patients with recurrent congestion despite on maximum tolerated diuretic dosage. Safety will be evaluated by the rate and severity of adverse events. Feasibility will be assess based on procedural success and time.

In demonstrating that this approach is both safe and feasible, the expected benefits of the research include symptom relief for patients as well as data generation and considerations for a novel treatment for chronic heart failure patients. Ultimately, this research will contribute to the development of an additional treatment option for patients that remain congested while on standard-of-care therapies.

Conditions

Interventions

PROCEDURE

Lymphatic Decompression

Patients will be prepared according to standard procedures Clinical examinations, para-clinical assessment and biological tests Patient will be set in angiography room and local anesthesia at the puncture area (femoral vein or brachial vein). Obtain access to the femoral vein per standard procedures (option for brachial access depending on anatomy based on pre-operative CT, per physician discretion) After setting introducer sheath, catheterism of cardiac cavity will be performed for assess the following standard hemodynamic measures Catheterism of thoracic duct through the subclavian vein will be performed under fluoro guidance and phlebography using contrast Measure TD and central venous pressures Deploy stent under fluoro guidance Standard vascular stent deployed in subclavian vein and into lymphovenous junction Evaluate the procedure with standard phlebography and hemodynamic measures Remove catheters, and temporary compression as standard venous procedures

Sponsors & Collaborators

  • Selera Medical

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2024-12-20
Completion
2024-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554912 on ClinicalTrials.gov