Trials / Suspended
SuspendedNCT04589065
SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)
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
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Lenar Yessayan · Academic / Other
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Selective Cytopheretic Device | SCD therapy will take place for 4 hours on day 1, 3, and 5 while on hemodialysis treatment. Participants will be continue to be followed until 30 days after the last SCD treatment. |
Timeline
- Start date
- 2025-09-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2020-10-19
- Last updated
- 2024-09-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04589065. Inclusion in this directory is not an endorsement.