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NCT03836482 · ClinicalTrials.gov registry record · NA
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
A NA study, sponsored by SeaStar Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03836482 is a NA study that is actively recruiting participants, run by SeaStar Medical. The registered enrollment target is 20 participants.
The verdict
NCT03836482, a NA study, is actively recruiting participants, sponsored by SeaStar Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model. This study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.
Interventions
- DEVICE Selective Cytopheretic Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-02 |
| Est. Completion | 2027-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836482
The ClinicalTrials.gov registry entry for NCT03836482 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SeaStar Medical, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Selective Cytopheretic Device is the first listed.
NCT03836482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03836482 about?
NCT03836482 is a clinical study titled "Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD". Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective t...
What is the current status of trial NCT03836482?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-10-02. Estimated completion is 2027-08.
What interventions are being tested in trial NCT03836482?
The interventions under investigation include: Selective Cytopheretic Device (DEVICE).
Who is sponsoring clinical trial NCT03836482?
This trial is sponsored by SeaStar Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.
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