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New treatment option 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 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.
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
- Recipient: To be eligible to participate in this study, a recipient must meet all the following criteria:
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
You likely can't join if
- Recipient:
- 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).
See the full eligibility criteria
- Recipient: To be eligible to participate in this study, a recipient must meet all the following criteria:
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
- Recipient:
- 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).
- Sensitized participants meeting any of the following:
- Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
- Participant undergoing any desensitization treatment (also with cPRA less than 50%)
- Participant with a positive prospective crossmatch and/or a positive virtual cross match Donor Inclusion Criteria: To be eligible to participate in this study, the donor heart must meet the following criteria:
- Estimated Cross Clamp Time ≥4 hours OR
- Estimated Cross Clamp ≥ 2 hours AND Any one or more of the following:
- 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
- Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD) Donor Exclusion Criteria: Donor hearts that meet any of the following criteria will be excluded from...
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.