Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
1 other identifier
interventional
90
1 country
25
Brief Summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
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 Nov 2020
25 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
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2022
CompletedResults Posted
Study results publicly available
June 21, 2024
CompletedJune 21, 2024
September 1, 2022
1.1 years
October 28, 2020
May 6, 2024
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Survival
Patient survival at 6 months post-transplant.
6 months post-transplant
Secondary Outcomes (1)
Utilization Rate
24 hours post transplant
Study Arms (1)
OCS Preservation
EXPERIMENTALInterventions
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Eligibility Criteria
You may qualify if:
- Primary heart transplant candidates
- Age ≥ 18 years old
- Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
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 (25)
University of California San Diago
La Jolla, California, 92037, United States
Cedars Sinai
Los Angeles, California, 90048, United States
Stanford University
Palo Alto, California, 94304, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern University
Evanston, Illinois, 60208, United States
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
University of Minnesota
Minneapolis, Minnesota, 55455-0213, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nyph/Cumc
New York, New York, 10032, United States
Montefiore
The Bronx, New York, 10467, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Duke University
Durham, North Carolina, 27710, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Sentara
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Damme, VP Clinical Affairs
- 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
October 28, 2020
First Posted
November 4, 2020
Study Start
November 25, 2020
Primary Completion
December 21, 2021
Study Completion
June 29, 2022
Last Updated
June 21, 2024
Results First Posted
June 21, 2024
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share