International EXPAND Heart Pivotal Trial
EXPANDHeart
International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
1 other identifier
interventional
75
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedStudy Start
First participant enrolled
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2019
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
August 1, 2019
2.6 years
December 18, 2014
December 23, 2024
December 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
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.
30 Days
Study Arms (1)
OCS Preservation
EXPERIMENTALOCS Preservation and Assessment
Interventions
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
Eligibility Criteria
You may qualify if:
- Registered male or female primary Heart transplant candidate
- Age ≥18 years old
You may not qualify if:
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (11)
Cedars-Sinai Medical Center
Los Angeles, California, 90211, United States
Indiana University
Indianapolis, Indiana, 46202, 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, 55407, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mount Sinai
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Damme
- Organization
- TransMedics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 23, 2014
Study Start
September 16, 2015
Primary Completion
April 25, 2018
Study Completion
March 2, 2019
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2019-08