International EXPAND Heart Pivotal Trial
- Conditions
- Heart Transplant
- Registration Number
- NCT02323321
- Lead Sponsor
- TransMedics
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Registered male or female primary Heart transplant candidate
- Age ≥18 years old
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation 30 Days A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (11)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Mount Sinai
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Scroll for more (1 remaining)Cedars-Sinai Medical Center🇺🇸Los Angeles, California, United States