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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03831048
Other study ID # OCS-CAR-03202019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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