Donors After Circulatory Death Heart Trial

TransMedics180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Heart Transplant

Interventions

OCS Heart SystemDEVICE

Preserving and assessing donor after circulatory death hearts for transplant

Cold StorageOTHER

Active comparator intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

University of California San Diago

La Jolla, California, United States

Outcomes

Primary Outcomes

Survival

Patient survival 6 months post-transplant

Time frame: 6 months

Secondary Outcomes

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.

Time frame: Within 24 hours post-transplant

Data from ClinicalTrials.gov

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