Donors After Circulatory Death Heart Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Heart Transplant

Intervention / Treatment
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* Device: OCS Heart System
* Other: Cold Storage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCD Heart Possible<br> | Device: OCS Heart System<br>* Preserving and assessing donor after circulatory death hearts for transplant<br>|
| Active Comparator: Standard of Care Heart Only<br> | Other: Cold Storage<br>* Active comparator intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Patient survival 6 months post-transplant | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart preservation, Beating heart transplant