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
XVIVO Perfusion
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, Impel…
Interventions
- DeviceNon-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Locations (14)
- UC San Diego HealthLa Jolla, California
- Cedars Sinai Medical CenterLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Stanford UniversityStanford, California
- Emory University HospitalAtlanta, Georgia
- Northwestern Memorial HospitalChicago, Illinois