N/A Completed N=75 Treatment

International EXPAND Heart Pivotal Trial

Heart Transplant

Source: ClinicalTrials.gov NCT02323321 ↗

Enrolled (actual)

Serious AEs

74.7%

Results posted

Jan 2025

Primary outcomePrimary: 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

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

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.