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XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
NCT06895070 · 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 Assist Transport (XHAT)
Study Locations (14)
California
- UC San Diego Health — La Jolla
- Cedars Sinai Medical Center — Los Angeles
- University of California Los Angeles — Los Angeles
- Stanford University — Stanford
New York
- NYU Langone — New York
- Columbia University Medical Center/New York Presbyterian Hospital — New York
Georgia
- Emory University Hospital — Atlanta
Illinois
- Northwestern Memorial Hospital — Chicago
Missouri
- Washington University - Barnes Jewish Health Hospital — St Louis
Nebraska
- University of Nebraska Medical Center — Omaha
North Carolina
- Duke University Medical Center — Durham
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-07-10 |
| Est. Completion | 2031-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06895070
The ClinicalTrials.gov registry entry for NCT06895070 describes a study currently listed as 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 60 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 3 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 Assist Transport (XHAT) 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: NCT06895070 reports 14 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Georgia. 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 NCT06895070 about?
NCT06895070 is a clinical study titled "XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)". 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 NCT06895070?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-07-10. Estimated completion is 2031-05.
What conditions does trial NCT06895070 study?
This clinical trial studies the following conditions: Heart Failure, Heart Transplant, 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 NCT06895070?
The interventions under investigation include: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06895070?
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 NCT06895070 being conducted?
This trial has 14 study locations across California, Georgia, Illinois, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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