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Donors After Circulatory Death Heart Trial
Not Recruiting
Trial ID: NCT03831048
Purpose
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.
Official Title
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
Stanford Investigator(s)
Yasuhiro Shudo, MD, PhD
Clinical Assistant Professor, Cardiothoracic Surgery
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.
Intervention(s):
device: OCS Heart System
other: Cold Storage
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305