Long Term Follow up Investigation of Endobronchial Valves in Emphysema (LIVE)

• FEV1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
  
  

• Modified Medical Research Council (mMRC) Questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score
  
  
• COPD Assessment Test (CAT) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)
  
  
• Survival over 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Survival status over the 5 year study period
  
  

• Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  Tabulation of adverse events occuring over the 5 year study period
  
  

Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.