Endobronchial Valve in Patients With Heterogeneous Emphysema
Endobronchial Valve in Patients With Heterogeneous Emphysema
To compare the clinical outcomes of Endoscopic Lung Volume Reduction using Pulmonx Zephyr
 Endobronchial Valve (EBV) vs. Standard of Care (SoC) in the treatment of heterogeneous
 emphysema patients in a controlled trial design setting.
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and
 compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in
 patients suffering from COPD with Heterogeneous Emphysema. Patients will be followed up for 6
 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm
 after the 6-month visit and will be followed up for 6 additional months.The primary objective
 is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary
 objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index)
 changes, target lobe volume reduction, as well as safety outcomes.
Inclusion Criteria:

 -  Consent form signed

 -  Heterogeneous emphysema on Chest CT Scanner

 -  Intact interlobar fissures adjacent to the target lobe on Chest CT or collateral
 ventilation negative in the target lobe by Chartis assessment

 -  Post bronchodilator Forced expiratory volume in 1 second (FEV1) < 50% predicted

 -  Total Lung Capacity > 100% predicted

 -  Residual Volume > 150% predicted

 -  PaO2 > 45mmHg

 -  Post rehabilitation 6 minute walk test > 140m

 -  No COPD exacerbation for at least 6 weeks

 -  Stopped cigarette smoking for more than 3 months

 Exclusion Criteria:

 -  Contraindication to bronchoscopy

 -  Tuberculosis, pleural effusion, or clinically significant bronchiectasis

 -  Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up

 -  Active pulmonary infection

 -  Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy

 -  Any extrapulmonary diseases compromising survival or evaluation within the protocol
 (severe cardiac disease, severe renal insufficiency, cancer…)

 -  Inclusion in an other study assessing respiratory treatments

 -  Pregnant or lactating woman