An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant

Condition(s) studied

Investigational drug(s) / intervention(s)

XVIVO Perfusion System (XPS™) with STEEN Solution™: XVIVO Perfusion System (XPS™) with STEEN Solution™

Study summary

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.

Eligibility

Primary outcome measure(s)

• Survival at 1 year post-transplant — 12 months
  Primary effectiveness endpoint
• Primary Graft Dysfunction (PGD) — 72 hours
  Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours

Trial sites (1)

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