Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Study Overview
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Brief Summary
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This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Detailed Description
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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.

Official Title
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Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Device: Zephyr Endobronchial Valve (EBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders of at least 18 years of age Understand and voluntarily sign an informed consent form. FEV1 > 15% predicted and < 45% predicted RV >180% predicted Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System Exclusion Criteria: • Active pulmonary infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main cohort<br>Patients of both genders of at least 18 years of age Who understand and voluntarily sign an informed consent form FEV1 > 15% predicted and < 45% predicted RV >180% predicted Diagnosis of emphysema with CT evidence of hyperinflation Absence of collateral ventilation according to Chartis Assessment System Treated with Zephyr Endobronchial Valve (EBV) | Device: Zephyr Endobronchial Valve (EBV)<br>* • Implantation of at least one Zephyr EBV following Chartis assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 5 years | 
| Survival over 5 years | Survival status over the 5 year study period | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valves, Endobronchial, Endoscopic lung volume reduction, Pulmonx, Zephyr, Chartis, Emphysema, COPD