Mind The Gap - Crossing Borders Study

Inclusion criteria

• Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
• Subjects of both genders of at least 35 years of age at the time of the baseline visit.
• Understand and voluntarily sign a patient informed consent form.
• 15 % predicted ≤ FEV1 ≤ 50% predicted.
• RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
• 6MWD ≥ 140 meters.
• Dyspnea score of ≥2 on the mMRC scale of 0-4.
• Non-smoker > 6 months prior to signing the informed consent.
• Chartis CV positive between target and ipsilateral lobe

Exclusion criteria

• Evidence of active pulmonary infection.
• Evidence of clinically significant bronchiectasis.
• History of more than 3 exacerbations with hospitalizations over the past 12 months.
• Myocardial infarction or other relevant cardiovascular events in the past 6 months.
• Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
• Prior endoscopic lung volume reduction.
• Unstable pulmonary nodule requiring follow-up
• Pregnant of nursing women.
• Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
• Any disease with high probability of mortality within 24 months.
• Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
• Patient was involved in other pulmonary drug studies within 30 days prior to this study.

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