Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For the person receiving the heart transplant (recipient):
- Adults aged 18 or older.
- People who have signed a consent form agreeing to take part in the study.
- People who are already on the waiting list for a heart transplant.
For the donor heart:
- Donor hearts where the estimated time the heart will be without blood flow is 4 hours or more.
- Donor hearts where the estimated time without blood flow is 2 hours or more, AND at least one of the following applies: the donor was aged 50 or older; the heart's pumping function was between 40–50% at a specific point in the assessment process; the donor had a period of no heartbeat lasting 20 minutes or more; the heart's wall has a certain level of thickening (between 12mm and 16mm); the donor's heart arteries show some irregularities but no major blockages; or the heart came from a donor whose heart stopped before donation (called donation after circulatory death, or DCD).
Who may not be able to join:
For the person receiving the heart (recipient):
- People who have previously had a solid organ transplant (such as a kidney or liver) or a bone marrow transplant.
- People who need more than one organ transplanted at the same time.
- People who are currently taking part in another clinical trial involving an experimental drug or medical device (participation in observational studies is allowed).
- People who are on certain types of heart support machines before the transplant, other than specific approved devices (a durable LVAD, Impella, or intra-aortic balloon pump).
- People with a history of complex heart conditions present from birth, such as having only one functioning heart chamber (confirm with trial site).
- People who are on kidney dialysis or another form of kidney replacement therapy.
- People who are on a ventilator (breathing machine) at the time of the transplant, or who are unable to give or confirm their consent.
- People whose immune system has developed certain antibodies that could attack the donor heart, specifically: those with a calculated immune sensitivity score above 50%; those undergoing any treatment to reduce immune sensitivity; or those whose blood tests show a likely incompatibility with the donor heart.
For the donor heart:
- Hearts from donors with unstable blood pressure or circulation requiring high doses of medication to keep the heart beating.
- Hearts with significant blockages in the heart's arteries (greater than 50% blockage in one or more vessels), or hearts with physical damage, abnormalities, or detectable artery disease found during final examination.
- Hearts with moderate to severe problems affecting the heart valves.
- Hearts that the investigating doctor decides should not be included in the trial.
- Hearts from donors who have previously had open chest (sternotomy) surgery.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sarah Lowe, XVIVO Perfusion
Phone: 617-283-8332
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The percentage of patient treatment success rate; The percentage of patient survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.