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Suspended Not applicable Interventional

SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)

ClinicalTrials.gov ID: NCT04589065

Public ClinicalTrials.gov record NCT04589065. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 8:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat Patients With NYHA Stage III or IV Heart Failure (HF) With Persistent Congestion and Worsening Renal Function as a Result of Cardiorenal Syndrome (CRS) That is Resistant to Optimal Medical Therapy Including Loop Diuretics

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit. Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.

Study identification

NCT ID
NCT04589065
Recruitment status
Suspended
Study type
Interventional
Phase
Not applicable
Lead sponsor
Lenar Yessayan
Other
Enrollment
10 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027
Last update posted
Sep 26, 2024

2025 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Michigan Ann Arbor Michigan 48109

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04589065, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 26, 2024 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04589065 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →