CompletedNot Applicable

International EXPAND Heart Pivotal Trial

United States75 participantsStarted 2015-09-16

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation

Timeframe: 30 Days

Trial details

NCT IDNCT02323321

SponsorTransMedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-25

Results submitted2024-12-23

View on ClinicalTrials.gov More Heart Transplant trials