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The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.
The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.
OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XVIVO Perfusion System (XPS™) with STEEN Solution™ | Device | XVIVO Perfusion System (XPS™) with STEEN Solution™ |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 1 year post-transplant | Primary effectiveness endpoint | 12 months |
| Primary Graft Dysfunction (PGD) | Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-transplant survival | Survival at 2, 3, 4 and 5 years post-transplant | 2 years, 3 years, 4 years and 5 years post-transplant |
| Pulmonary Function Test (FEV1) | Pulmonary Function Test (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is the key lung function test in diagnosing BOS. FEV1 test at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. |
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This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.
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This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Lowe | XVIVO Perfusion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D056951 | Photoelectron Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 1 year, 2 years, 3 years, 4 years and 5 years post-transplant |
| Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD) | Rate of Grade 0 through 3 Bronchiolitis Obliterans Syndrome (BOS) at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Clinically, BOS is associated with a progressive decline in forced expiratory volume in one second (FEV1) greater than or equal to 20% of baseline. Decline in FEV1 % increases the risk of development of BOS (Grade 0 to 3). CLAD is defined as a substantial and persistent decline (≥ 20%) in measured FEV1 value from the reference (baseline) value after lung transplantation, with or without a change in FVC. If CLAD is identified, staging and phenotype will be assigned. | 1 year, 2 years, 3 years, 4 years and 5 years post-transplant |
| Hospitalizations | The presence of in-patient hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant | 1 year, 2 years, 3 years, 4 years and 5 years post-transplant |
| Acute Rejection Episodes | The presence of biopsy proven hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant | 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant |
| Karnofsky Performance Status Scale (KPS)/Karnofsky score | Karnofsky Performance Status Scale is an assessment tool for functional impairment. It is used to improve understanding of patient needs, ability to carry out daily activities and to assess patient prognosis. Karnofsky score is calculated at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Higher the Karnofsky score, better the ability to carry out daily activities. | 1 year, 2 years, 3 years, 4 years and 5 years post-transplant |
| Safety Endpoint | XPS related SAEs from transplant to 30 days post-transplant or initial hospital stay, whichever is longer | 30 days post-transplant |