Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Abbas Ardehali, MD
Headshot of Abbas Ardehali
Abbas Ardehali

Description

Summary

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.

Official Title

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

Details

This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.

Keywords

Heart Transplant, Heart Failure, Transplant; Failure, Heart, Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

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.

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles 5368361 California 5332921 90095-1405 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha 5074472 Nebraska 5073708 69198-2265 United States

Lead Scientist at UCLA

  • Abbas Ardehali, MD
    Dr. Abbas Ardehali holds the William E. Connor Chair in Cardiothoracic Transplantation.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
XVIVO Perfusion
Links
Sign up for this study
ID
NCT06895070
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated