N/A
N=180
Donors After Circulatory Death Heart Trial
Heart Transplant
Bottom Line
View on ClinicalTrials.gov: NCT03831048 ↗Enrolled (actual)
180
Serious AEs
74.4%
Results posted
May 2024
Primary outcome: Primary: Survival — 76; 75 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCS Heart System (Device); Cold Storage (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
76; 75 | <0.0001 sig |
| SECONDARY Utilization Rate |
80 | — |
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 transplantation.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03831048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.