N/A
N=75
International EXPAND Heart Pivotal Trial
Heart Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02323321 ↗Enrolled (actual)
75
Serious AEs
74.7%
Results posted
Jan 2025
Primary outcome: Primary: Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation — 66 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preservation of Hearts for Transplantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation |
66 | <0.0001 sig |
Summary
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation
Eligibility Criteria
Inclusion Criteria
- Registered male or female primary Heart transplant candidate
- Age ≥18 years old
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 (NCT02323321). 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.