Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung

Fecha de inicio: 1 de septiembre de 2012

Inclusion Criteria: Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation Age from 40 to 75 years BMI < 32 kg/m2 FEV1 < 40% of predicted value, FEV1/FVC < 70% TLC > 120% predicted, RV > 150% predicted. Stable with < 20 mg prednisone (or equivalent) qd PaCO2 < 50mm Hg PaO2 > 45 mm Hg on room air 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation) Nonsmoking for 4 months prior to initial interview and throughout screening The patient agrees to all protocol required follow-up intervals. The patient has no child bearing potential The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria Prior endobronchial treatment for emphysema Pleural or interstitial disease that precludes surgery. Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy. Clinically significant bronchiectasis Pulmonary nodule requiring surgery History of recurrent respiratory infections (> 3 hospitalization in the last year) Clinically significant (> 4 Tablespoons per day) sputum production Fever, elevated white cell count, or other evidence of active infection Dysrhythmia that might pose a risk during exercise or training Congestive heart failure within 6 mo and LVEF < 45% Evidence or history of Cor Pulmonale Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT History of exercise-related syncope MI within 6 mo and LVEF < 45% Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period Any disease or condition that interferes with completion of initial or follow-up assessments Patient is currently enrolled in another clinical trial Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer Alpha-1-Antitrypsin Deficiency