Donors After Circulatory Death Heart Trial

Heart Transplant Clinical Trial

Official title:

Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831048
• Other study ID #: OCS-CAR-03202019
• Status: Completed
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: September 28, 2021

Study information

• Verified date: December 2022
• Source: TransMedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness 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.

Description:

A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 28, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Donor Inclusion

• Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST)

• Donor age 18-49 years old inclusive

• Warm ischemic time (WIT) = 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor.

Donor Exclusion

• Previous cardiac surgery

• Known coronary artery disease

• Cardiogenic shock or myocardial infarction, or

• Sustained terminal ejection fraction (EF) of = 50%, or

• Significant valve disease except for competent bicuspid aortic valve

Recipient Inclusion

• 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' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.

Recipient Exclusion

• Prior solid organ or bone marrow transplant

• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

• Multi-organ transplant

• Investigator unwilling to randomize to either arm.

Related Conditions & MeSH terms

• Heart Transplant

Intervention

Device:
• OCS Heart System
Preserving and assessing donor after circulatory death hearts for transplant

Other:
• Cold Storage
Active comparator intervention

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	Northwestern Medicine	Chicago	Illinois
United States	Duke University	Durham	North Carolina
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	Florida
United States	Stanford University	Palo Alto	California
United States	Virgina 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	Survival	Patient survival 6 months post-transplant	6 months
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.	Within 24 hours post-transplant