OCS Heart Perfusion Post-Approval Registry

Study Overview
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Brief Summary
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The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Detailed Description
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Multi-center, observational post-approval registry to: compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

Official Title
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OCS Heart Perfusion (OHP) Post-Approval Registry

Conditions
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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: Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System. Recipient Exclusion Criteria: Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or On renal dialysis at time of transplant. Donor Exclusion Criteria (for DCD Donor Hearts only): Warm ischemic time > 30 minutes (warm ischemic time is 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).

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCS DBD Heart Primary Analysis Population<br>200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or On renal dialysis at time of transplant | Device: OCS Heart System<br>* The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.<br>|
| OCS DCD Heart Primary Analysis Population<br>150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or On renal dialysis at time of transplant Transplanted with DCD heart with warm ischemic time > 30 minutes (warm ischemic time is 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). | Device: OCS Heart System<br>* The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.<br>|
| Other OCS Heart Analysis Population<br>Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD). | Device: OCS Heart System<br>* The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival | Patient survival at one-year post-heart transplant. | One year post-heart transplant |