XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
Purpose
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.
Conditions
- Heart Failure
- Transplant; Failure, Heart
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation Recipient
Exclusion Criteria
- 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 Exclusion Criteria: 1. Unstable hemodynamics requiring high-dose inotropic support. 2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels. 3. Moderate to severe cardiac valve pathology. 4. Investigator's clinical decision to exclude from trial. 5. Previous Sternotomy.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Subjects requiring a Heart Transplant |
Device: Preservation of hearts for transplant. |
|
Recruiting Locations
Vanderbilt University
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- XVIVO Perfusion
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).