Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Study Overview
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Brief Summary
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Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Detailed Description
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Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Official Title
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Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Device: EBV implantation
* Device: IBV implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 % heterogeneous emphysema Exclusion Criteria: homogeneous emphysema significant bronchiectasis severe concomitant diseases pregnancy

Ages Eligible for Study
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Minimum Age: 30 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endobronchial valves (EBV)<br>Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves | Device: EBV implantation<br>* In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.<br>* Other names: (Zephyr EBV);|
| Active Comparator: Intrabronchial valves (IBV)<br>Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves | Device: IBV implantation<br>* In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.<br>* Other names: (Spiration IBV);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pulmonary function (FEV1 and RV/TLC) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe adverse events |  | 6 months | 
| Evaluation of valve migration rate |  | 6 months | 
| Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC) |  | 6 months | 
| Average changes in 6-minute-walk-distance |  | 6 months |