N/A
Completed N=90
Donor After Circulatory Death Heart CAP Trial
Heart Transplant
Source: ClinicalTrials.gov NCT04615182 ↗
Enrolled (actual)
90
Serious AEs
58.9%
Results posted
Jun 2024
Primary outcomePrimary: Patient Survival — 75 Participants
Summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival |
75 | — |
| SECONDARY Utilization Rate |
83 | — |
Eligibility Criteria
Recipient Inclusion Criteria:
- • 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' UNOS/OPTN data and recipients' INTERMACS data.
Recipient Exclusion Criteria:
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant.
Data sourced from ClinicalTrials.gov (NCT04615182). 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. Informational only — not medical advice.