Trial Search Results

Donors After Circulatory Death Heart Trial

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

TransMedics

Stanford Investigator(s):

Intervention(s):

  • Device: OCS Heart System
  • Other: Cold Storage

Phase:

N/A

Eligibility


Donor Inclusion

   - Maastricht Category III DCD donor, defined as expected death after the withdrawal of
   life- supportive therapy (WLST)

   - Donor age 18-49 years old inclusive

   - Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when
   mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to
   aortic cross-clamp and administration of cold cardioplegia in the donor.

Donor Exclusion

   - Previous cardiac surgery

   - Known coronary artery disease

   - Cardiogenic shock or myocardial infarction, or

   - Sustained terminal ejection fraction (EF) of ≤ 50%, or

   - Significant valve disease except for competent bicuspid aortic valve

Recipient Inclusion

   - Primary heart transplant candidates

   - Age ≥ 18 years old

   - Signed: (1) written informed consent document; (2) authorization to use and disclose
   protected health information; and (3) consent to TransMedics' use of recipients'
   United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network
   (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory
   Support (INTERMACS) data.

Recipient Exclusion

   - Prior solid organ or bone marrow transplant

   - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

   - Multi-organ transplant

   - Investigator unwilling to randomize to either arm.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting