This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.
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.
Study Type
OBSERVATIONAL
Enrollment
628
• Implantation of at least one Zephyr EBV following Chartis assessment
Heidelberg Hospital
Heidelberg, Germany
FEV1
Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
Time frame: 2 years
Modified Medical Research Council (mMRC) Questionnaire
Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score
Time frame: 5 years
COPD Assessment Test (CAT)
Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)
Time frame: 5 years
Survival over 5 years
Survival status over the 5 year study period
Time frame: 5 years
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