Heart EXPAND Continued Access Protocol

Study Overview
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Brief Summary
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The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

Detailed Description
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To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.

Official Title
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Heart Expand Continued Access Protocol

Conditions
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Heart Transplant

Intervention / Treatment
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* Device: OCS Heart System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (DONOR): At least one of the following: Expected total cross-clamp time of ≥ 4 hours Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of >12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram. Exclusion CAD with > 50% stenosis on angiogram, or Cardiogenic shock or myocardial infarction, or EF consistently < 40%, or Significant valve disease except for competent bicuspid aortic valve. Eligibility Criteria (RECIPIENT) Registered primary heart transplant candidate Age >18 years old Written informed consent. Exclusion Prior solid organ or bone marrow transplant Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis Multi-organ transplant.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Preservation<br> | Device: OCS Heart System<br>* The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Patient survival post transplant | 30 days | 
| Absence of severe PGD | Absence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post transplant | 24 hours post heart transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Patient and graft survival | 30 days | 
| Incidence of severe PGD | Incidence of severe primary heart graft dysfunction of left and/or right ventricle in the first 24 hours post heart transplant | 24 hours post transplant | 
| Donor heart utilization rate | The proportion of eligible donor hearts that were successfully transplanted after preservation and assessment on the OCS Heart System | 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