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XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
NCT05881278 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
Conditions Studied
Interventions
- DEVICE Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study Locations (20)
California
- University of California San Diego — La Jolla
- Cedars-Sinai — Los Angeles
- David Geffen School of Medicine at UCLA — Los Angeles
- Stanford Medicine — Palo Alto
New York
- NYU Langone Health — New York
- Columbia University Irving Medical Center/New York Presbyterian Hospital — New York
- Montefiore Medical Center — The Bronx
Maryland
- University of Maryland Medical Center/University of Maryland, Baltimore — Baltimore
- Johns Hopkins Medicine — Baltimore
Ohio
- Cleveland Clinic Foundation — Cleveland
- Ohio State University — Columbus
Georgia
- Emory University — Atlanta
Illinois
- Northwestern Memorial Hospital — Chicago
Missouri
- Washington University - Barnes Jewish Hospital — St Louis
Nebraska
- University of Nebraska Medical Center — Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2023-10-10 |
| Est. Completion | 2029-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05881278
The ClinicalTrials.gov registry entry for NCT05881278 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XVIVO Perfusion, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05881278 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05881278 about?
NCT05881278 is a clinical study titled "XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)". The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
What is the current status of trial NCT05881278?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 141 participants. The study started on 2023-10-10. Estimated completion is 2029-11.
What conditions does trial NCT05881278 study?
This clinical trial studies the following conditions: Heart Failure, Transplant; Failure, Heart. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05881278?
The interventions under investigation include: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05881278?
This trial is sponsored by XVIVO Perfusion, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05881278 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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