An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
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:
This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.