XVIVO Heart Box for Heart Transplant
This study is looking at a new way to preserve and transport donor hearts for transplantation using the XVIVO Heart Preservation System (XHPS). This system uses Non-Ischemic Heart Preservation (NIHP), which means the heart is kept without blood flow, to see if it's safe and effective for hearts that might not meet standard donation criteria. The goal is to see how many patients successfully receive a transplant and how many are still alive one year later. You could be eligible if you are 18 or older, are waiting for a heart transplant, and have signed a consent form. This is a continuation of a previous study to gather more information while the system is being reviewed for wider use.
- Study design
- This study is an interventional study with a planned enrollment of 60 participants. It is a continuation of a previous trial to gather additional data.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days after transplantation to measure treatment success, and for 365 days (one year) to measure survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
At a glance
Conditions
NCT06895070
Where you'd take part
This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Columbia University Medical Center/New York Presbyterian Hospital
New York, New Yorkstudy coordinator listed
Recruiting
Duke University Medical Center
Durham, North Carolinastudy coordinator listed
Recruiting
Emory University Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Northwestern Memorial Hospital
Chicago, Illinoisstudy coordinator listed
Recruiting
NYU Langone
New York, New Yorkstudy coordinator listed
Recruiting
Stanford University
Stanford, Californiastudy coordinator listed
Recruiting
UC San Diego Health
La Jolla, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sarah Lowe · STUDY_DIRECTOR · XVIVO Perfusion
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- The percentage of patient treatment success rate30 days post transplantation
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
- The percentage of patient survivalPost-operative Day 365.
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.