Heart Failure, Heart Transplant, Transplant; Failure, Heart
Conditions
Brief 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.
Detailed 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.
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)
Sponsors
XVIVO Perfusion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patient treatment success rate | 30 days post transplantation | The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure. |
| The percentage of patient survival | Post-operative Day 365. | The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival. |
Countries
United States
Contacts
CONTACTAmanda Carpenter
CONTACTJen Ruel
STUDY_DIRECTORSarah Lowe
XVIVO Perfusion
Outcome results
None listed