Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
XVIVO Perfusion
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥18 years.
2. Signed informed consent form (ICF).
3. Listed for heart transplantation
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.
You may not be if
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.
