XVIVO Heart Box non-ischemic preservation for transporting donor hearts.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This continuation of the PRESERVE IDE work uses the XVIVO Heart Assist Transport (XHAT) system and supplemented XVIVO Heart Solution to perform non-ischemic preservation on donor hearts that may not meet standard acceptance criteria with the intention of transplanting them. Donor hearts are maintained on the device during transport to reduce ischemic injury and support organ viability. Adult recipients listed for isolated heart transplantation at participating centers who meet inclusion and exclusion criteria may receive these transported hearts under this continued access protocol while a PMA is being pursued. The protocol excludes multi-organ transplants, prior solid organ or bone marrow recipients, those on certain forms of mechanical support or dialysis, ventilator-dependent patients, and some highly sensitized or complex congenital heart cases.

Why it matters

Who can join: the full rules

Inclusion Criteria Recipient:

To be eligible to participate in this study, a recipient must meet all the following criteria:

1. Age ³18 years.
2. Signed informed consent form (ICF).
3. Listed for heart transplantation.

Exclusion Criteria Recipient:

1. Previous solid organ or bone marrow transplantation.
2. Requires a multi-organ transplant.
3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
6. Subject on renal replacement therapy/dialysis.
7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
8. 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:

1. Estimated Cross Clamp Time ≥4 hours OR
2. 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 transplantation in this study:

1. Unstable hemodynamics requiring high-dose inotropic support.
2. 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.
3. Moderate to severe cardiac valve pathology.
4. Investigator's clinical decision to exclude from trial.
5. Previous sternotomy.

Where it's running

• UC San Diego Health
  La Jolla, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Amanda Carpenter
• Email: Amanda.Carpenter@xvivogroup.com
• Phone: 617-283-8332

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.