Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
TransMedics
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least one of the following:
Expected total cross-clamp time of ≥ 4 hours
Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of \>12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.
Exclusion
CAD with \> 50% stenosis on angiogram, or
Cardiogenic shock or myocardial infarction, or
EF consistently \< 40%, or
Significant valve disease except for competent bicuspid aortic valve.
Eligibility Criteria (RECIPIENT)
Registered primary heart transplant candidate
Age \>18 years old
Written informed consent. Exclusion
Prior solid organ or bone marrow transplant
Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis
Multi-organ transplant.
Clareo Health | Heart EXPAND Continued Access Protocol
