Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

• Centralized Lung Evaluation System (Device): Assessment of allograft lung for transplant suitability
• Lung Transplant (Procedure): Orthotopic single or double lung transplantation.

Primary outcomes

• 12 Month Survival or Freedom From Mortality [12 Months]: Survival at 12 months following lung transplantation

Sex: All, ages: 18 Years to any

Each patient must meet all of the following criteria to be enrolled in the Study:

1. 18 years of age or older.
2. Male or female.
3. Patient actively awaiting a single or double lung transplant.
4. Patient or patient's representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures.
5. Patient matches with and undergoes a transplant with a donor lung.

Patients who meet any of the following criteria will be excluded from the study:

1. Patients listed for same-side lung re-transplantation.
2. Patients listed for multiple organ transplantation including lung and any other organ.
3. Patients listed for live donor lobar lung transplant.
4. Patients positive for human immunodeficiency virus (HIV ) or Burkholderia cenocepacia infection.
5. Patient receives a standard of care (non-EVLP ) lung transplant but does not match to an EVLP subject based on the criteria for control matching.
6. Transplanted with a lung that was perfused using another EVLP technology.
7. Participating in another respiratory or cardiovascular clinical trial.

Participant flow

Outcome results

• 12 Month Survival or Freedom From Mortality (Primary), Number, Percent: EVLP Group 84 (75.0 to 90.8); Control Group 92.5 (84.4 to 97.2)

Adverse events

Time frame: From transplantation through 12 months post-transplant

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2021-01-28)
• Statistical Analysis Plan (PDF, 2021-01-28)