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This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions. Clinical data from up to 5000 transplant recipients will be included in the registry at up to 20 U.S. transplant centers. This registry will include clinical data collected retrospectively from medical records of recipients already transplanted before the initiation of the registry and any new recipients of livers that meet donor selection criteria. This registry introduces no contact with the transplant recipient and registry participants will follow standard of care. Data will be collected through up to 5 years of standard of care clinical follow-up.
This registry represents minimal risk to the transplant recipients being studied. The participants included in this registry will have undergone transplant surgery with a deceased donor liver graft that was perfused using the VitaSmart HOPE System, a medical device that is cleared by the Food and Drug Administration (FDA) for commercial use in the U.S. All perfusions of deceased donor liver grafts will be performed in accordance with standard medical practice.
The objectives of this registry is to Evaluate the safety and efficacy of HOPE prior to liver transplantation in real-world clinical settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing liver transplantation with a donor graft that was perfused using VitaSmart | Recipients who received a deceased donor liver graft that was perfused using VitaSmart hypothermic oxygenated perfusion therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions | Device | Observational, real-world use of the VitaSmart HOPE System with a donor liver graft under standard of care conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recipients alive with functioning graft at 1-year post-transplant | Number of Recipients alive with functioning graft at 1-year post-transplant (absence of graft failure or death for liver related reasons) | 1-year post-transplant |
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Inclusion Criteria:
1. Liver graft accepted for transplant and perfused using the VitaSmart HOPE System
Exclusion Criteria:
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Patients (recipients) undergoing liver transplantation with a deceased donor liver graft that was perfused using the VitaSmart HOPE System.
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| Name | Affiliation | Role |
|---|---|---|
| David Foley, MD | University of Wisconsin, Madison | Study Chair |
| Andrea Schlegel, MD, MBA | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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