Lymph Drainage in Heart Failure

NCT ID: NCT05240638

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-24

Study Completion Date

2023-07-07

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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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TD Drainage

Short term TD drainage

Group Type EXPERIMENTAL

TD Drainage

Intervention Type DEVICE

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

Interventions

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TD Drainage

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marat Fudim, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Marat Fudim

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00107814

Identifier Type: -

Identifier Source: org_study_id

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