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XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the XVIVO system can safely preserve and transport donor hearts with added risk factors for a heart transplant. It is for adults who are on a heart transplant waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old, be listed for a heart transplant, and sign a form agreeing to join the study.
  • The donor heart must have an expected cross-clamp time of at least 4 hours, or at least 2 hours with one of the risk factors below. Cross-clamp time is the time blood flow is stopped for the transplant.
  • For the 2-hour option, donor risk factors include: age 50 or older; heart pumping strength of 40%–50%; downtime of at least 20 minutes; heart wall thickness over 12 mm but no more than 16 mm; or uneven heart artery walls without major artery disease.
  • Hearts donated after the donor's blood flow has stopped may also qualify.

Who can't join

  • You have had an organ or bone marrow transplant before, or you need more than one organ transplanted.
  • You are taking part in another study testing a drug or medical device. Studies that only observe patients are allowed.
  • Before transplant, you use a machine to help blood flow other than a long-term LVAD heart pump, an Impella heart pump, or an intra-aortic balloon pump.
  • You have a complex heart problem present since birth, such as having only one working lower heart chamber. The study doctor and XVIVO review this.
  • You need dialysis or another treatment that replaces kidney function, or you depend on a breathing machine at transplant and cannot give or confirm consent.
  • You have high levels of antibodies that may attack a donor heart: a cPRA score over 50%, treatment to lower these antibodies, or a positive actual or computer-based donor matching test.
  • The donor heart needs high doses of drugs to keep blood flow stable; has an artery narrowed by more than 50%; has bruising, damage, other major problems, or artery disease found by touch; or has moderate to severe valve disease.
  • The donor has had surgery that opened the breastbone, or the study doctor decides not to use the donor heart.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (14)

CA

GA

IL

MO

NC

NE

NY

TN

TX

WA