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NCT04615182 Clinical Trial

Donor After Circulatory Death Heart CAP Trial

Heart Transplant Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04615182
Other study ID # OCS-CAR-08242020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2020
Est. completion date June 29, 2022

Study information
Verified date September 2022
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date June 29, 2022
Est. primary completion date December 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Recipient Inclusion Criteria: - • 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. Recipient Exclusion Criteria: - Prior solid organ or bone marrow transplant - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency - Multi-organ transplant.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transplant
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.

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Bronx New York
United States Duke University Durham North Carolina
United States Northwestern University Evanston Illinois
United States St. Vincent Cardiovascular Research Institute Indianapolis Indiana
United States Mayo Clinic Florida Jacksonville Florida
United States University of California San Diago La Jolla California
United States Cedars Sinai Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin
United States Minneapolis Heart Institute Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Nyph/Cumc New York New York
United States Sentara Norfolk Virginia
United States University of Nebraska Medical Center Omaha Nebraska
United States AdventHealth Orlando Orlando Florida
United States Stanford University Palo Alto California
United States Virginia Commonwealth University Richmond Virginia
United States Tampa General Hospital Tampa Florida
United States Westchester Medical Center Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Survival Patient survival at 6 months post-transplant. 6 months post-transplant
Secondary Utilization Rate Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit per protocol and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System. 24 hours post transplant
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