Clinical Research Directory

Subject Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Male or female patients * All patients, 18 years of age or older * Patient already on or added to the active waiting list for a single or bilateral lung transplant * Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant * Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant Subject Exclusion Criteria: A subject who meets any of the following criteria will be excluded from participation: * 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 transplant * Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia * Patients not initially consented into the study prior to the time of lung transplant * Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS). Donor Lung Inclusion Criteria for EVLP Assessment: The donor lung must meet at least one of the following criteria to proceed with EVLP: * At the time of the clinical evaluation, the donor PaO2/FiO2 \< 300 mmHg * Donor received ≥ 10 units of blood transfusions * Donation after Cardiac Death (DCD) donor * Expected cold ischemic time \> 6 hours * Donor age ≥ 55 years old * Study Center Investigator requires additional assessment ex vivo and/or extended preservation time Donor Lung Exclusion Criteria for EVLP Assessment: The donor lung is excluded from EVLP if at least one of the following criteria have been met: * The donor lung has confirmed pneumonia and/or persistent purulent secretions identified via bronchoscopy * Non-persistent purulent secretions that do not clear by hour 3 on EVLP * The donor lung has confirmed evidence of aspiration * The donor lung has significant mechanical lung injury or trauma * The cold ischemic time, starting at donor aortic cross clamp/ initial flush (CIT-1), required to transport the lung from the donor site to start of the EVLP procedure at SPONSOR's facility \> 10 hours EVLP Lung Inclusion Criteria for Transplantation: The donor lung must meet each of the following conditions post-EVLP for transplant suitability consideration by the Study Center Investigator: * PvO2/FiO2 ≥ 350 mmHg at final EVLP evaluation time period * and \< 15% increase from baseline value (defined as the first hour collection point) to final value of pulmonary vascular resistance (PVR) * and \< 15% increase from baseline value to final value of peak airway pressure (PawP) * and \< 15% decrease from baseline value to final value of static lung compliance (Cstat) * and the total preservation time (TPT) does not exceed the following: * the initial CIT-1 time from donor to EVLP \> 1 hour and ≤ 10 hours * the EVLP time \> 3 hours and ≤ 6 hours * the second CIT-2 from EVLP cool down to beginning of recipient implantation must be \> 1 hour and ≤ 6 hours for the first lung * the second CIT-2 from EVLP cool down to beginning of recipient implantation must be \> 1 hour and ≤ 10 hours for the second lung * and Study Center Investigator deems lung function suitable for intended subject EVLP Lung Exclusion Criteria for Transplantation: The donor lung is excluded from transplant inclusion if at least one of the following criteria have been met: * PvO2/FiO2 \< 350 mmHg at final EVLP evaluation time period * or ≥ 15% increase from baseline value to final value of pulmonary vascular resistance (PVR) * or ≥ 15% increase from baseline value to final value of peak airway pressure (PawP) * or ≥ 15% decrease from baseline value to final value of static lung compliance (Cstat) * or TPT exceeds any of the following conditions: * CIT-1 \< 1 hour or \> 10 hours * EVLP \< 3 hours or \> 6 hours * CIT-2 \< 1 hour or \> 6 hours for first lung or \> 10 hours for second lung * or Study Center investigator deems lung function unsuitable for intended subject