Heart Failure, 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
PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).
Interventions
DEVICENon-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
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 Inclusion Criteria: 1. Age ≥18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation Recipient
Exclusion criteria
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. 5. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion). 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 subject is undergoing desensitization treatment. Donor Inclusion Criteria: 1. Estimated Cross Clamp Time ≥ 4 hours, OR 2. Estimated Cross Clamp Time ≥ 2 hours, AND Any ONE or more of the following: * Age ≥ 50 years * LVEF 40-50% at time of provisional acceptance * Down-time ≥ 20 mins * Hypertrophy/Septal thickness \>12- ≤16mm * Angiographic luminal irregularities with no significant CAD, OR 3. Donation after Circulatory Death (DCD) donors. Donor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORSarah Lowe
XVIVO Perfusion
Outcome results
None listed