Status:
COMPLETED
Donors After Circulatory Death Heart Trial
Lead Sponsor:
TransMedics
Conditions:
Heart Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criter...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03831048
Start Date
November 26 2019
End Date
September 28 2021
Last Update
May 7 2024
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Diago
La Jolla, California, United States, 92037
2
Cedars Sinai
Los Angeles, California, United States, 90048
3
Stanford University
Palo Alto, California, United States, 94304
4
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510