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

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

The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.

Inclusion Criteria:

• Male or female;
• Aged 18 years or older;
• Informed consent is given for participation in the Study by the patient or patient's designated representative; and
• Patient undergoes lung transplantation.

Exclusion Criteria:

• Patients listed for same-side lung re-transplantation.
• Patients listed for multiple organ transplantation including lung and any other organ.
• Patients listed for live donor lobar lung transplant.
• Patients positive for human immunodeficiency virus (HIV) or Burkholderia cenocepacia infection.
• 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.
• Participating in another interventional trial