Clinical trial for Heart Transplant
Official title XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
ClinicalTrials.gov ID: NCT06895070
What this study is testing
- What it's testing
- The study aims to find out if a non‑ischemic (no blood‑flow stop) preservation method using the XVIVO Heart Preservation System safely keeps donor hearts viable for transplant.
- Who it's for
- Adults who are candidates for a heart transplant and will receive a donor heart preserved with this system.
- What's involved
- Donor hearts will be stored and transported using the XVIVO Heart Box and solution, and the outcomes of the transplant will be tracked.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
You likely can't join if
- Previous solid organ or bone marrow transplantation.
- Requires a multi-organ transplant.
- Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are...
- Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
- History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
- Subject on renal replacement therapy/dialysis.
See the full eligibility criteria
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
- Previous solid organ or bone marrow transplantation.
- Requires a multi-organ transplant.
- Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
- Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
- History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
- Subject on renal replacement therapy/dialysis.
- Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
- Participant undergoing any desensitization treatment (also with cPRA less than 50%)
- Estimated Cross Clamp Time ≥4 hours OR
- Age ≥50 years
- LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
- Down-time ≥20 minutes
- Hypertrophy septal thickness \>12 - ≤16mm
- Unstable hemodynamics requiring high-dose inotropic support.
- Significantly abnormal coronary angiogram defined as CAD \> 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.
- Moderate to severe cardiac valve pathology.
- Investigator's clinical decision to exclude from trial.
- Previous sternotomy.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Los Angeles, California, United States
- Stanford, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Los Angeles, California, United States; Stanford, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; St Louis, Missouri, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.