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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Heart Transplant

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
Other	Patient and graft survival	Patient and graft survival at 30 days post-transplant	30 days post-transplant
Other	Patient and graft survival	Patient and graft survival at 30 days or initial hospital discharge, if later than 30 days	30 days or initial hospital discharge, if later than 30 days
Other	Primary Graft Dysfunction (PGD)	Severe heart primary graft dysfunction (PGD) (left or right ventricle) (not including rejection or cardiac tamponade) according to ISHLT consensus manuscript	24 hours post transplant
Other	Post-Transplant Mechanical Circulatory Support	Use of post-transplant mechanical circulatory support (LVAD, RVAD, BiVAD) for > 72 hours immediately post-transplant.	> 72 hours immediately post-transplant
Other	Patient survival	Patient survival at 1 year after transplant.	1 year after transplant.
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 above 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