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

PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol

This program tests whether the XVIVO non-ischemic heart preservation system can safely preserve extended-criteria donor hearts for adults waiting for a heart transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: XVIVO Perfusion (Industry-sponsored)
• Locations: 14 sites (La Jolla, California and 13 other locations)
• Trial ID: NCT06895070 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18 years or older) listed for isolated heart transplant at a participating center who can consent and do not meet exclusion criteria such as prior solid organ transplant, need for dialysis, or certain mechanical circulatory supports.

Not a fit: Patients requiring multi-organ transplant, those on renal replacement therapy/dialysis, ventilator-dependent patients, prior solid-organ transplant recipients, or those with disqualifying complex congenital heart disease are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could increase the number of usable donor hearts and improve transplant outcomes by better preserving higher-risk donor hearts during transport.

How similar studies have performed: Earlier PRESERVE IDE data and other reports of non-ischemic preservation have shown encouraging safety and organ viability signals, but broader regulatory approval and larger confirmatory data are still pending.

Eligibility criteria

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 this trial is running

La Jolla, California and 13 other locations

• 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)
• Washington University - Barnes Jewish Health Hospital — St Louis, Missouri, United States (Recruiting)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• NYU Langone — New York, New York, United States (Recruiting)
• Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• University of Washington Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Amanda Carpenter

Conditions Heart Transplant; Heart Failure; Transplant; Failure, Heart