N/A
N=90
Donor After Circulatory Death Heart CAP Trial
Heart Transplant
Bottom Line
View on ClinicalTrials.gov: NCT04615182 ↗Enrolled (actual)
90
Serious AEs
58.9%
Results posted
Jun 2024
Primary outcome: Primary: Patient Survival — 75 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transplant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival |
75 | — |
| SECONDARY Utilization Rate |
83 | — |
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)
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.