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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: Recruiting NA study, sponsored by SeaStar Medical.
NCT03836482 is a NA study that is actively recruiting participants, run by SeaStar Medical. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Need for continuous IV vasopressor support with \>5 total norepinephrine equivalents and/or \>3 vasopressor agents \>4 hours following termination of daily SCD therapy session to maintain a MAP \>60 mmHg, with norepinephrine equivalents defined as: 1. 1 x epinephrine (ug/kg/min) 2. 001 x dopamine (ug/kg/min) 3. 0.06 x phenylephrine (ug/kg/min) 4. 2.5 x vasopressin (U/min) (Note that use of inotropes (i.e., dobutamine and milrinone) or dopamine at ≤3 mcg/kg/min are not components of this measur
Interventions
- DEVICE Selective Cytopheretic Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-02 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT03836482 shows while recruiting
NCT03836482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Selective Cytopheretic Device is the first listed.
NCT03836482 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03836482's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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