Donors After Circulatory Death Heart Trial

TransMedics

Status: Completed

Conditions: Heart Transplant

Treatments: Device: OCS Heart System; Other: Cold Storage

Study type: Interventional

Funder types: Industry

Identifiers

NCT03831048

OCS-CAR-03202019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

DCD Heart Possible

Experimental group

Treatment:

Device: OCS Heart System

Standard of Care Heart Only

Active Comparator group

Treatment:

Other: Cold Storage