Trial Search Results

Heart EXPAND Continued Access Protocol

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

TransMedics

Stanford Investigator(s):

Intervention(s):

  • Device: OCS Heart System

Phase:

N/A

Eligibility


Inclusion Criteria (DONOR):

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting