Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function (EMPROVE)
Emphysema
About this trial
This is an interventional treatment trial for Emphysema focused on measuring Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, COPD, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, BLVR, TLVR, Emphysema, Pulmonary Emphysema, Pathologic Process, Lung Diseases, Respiratory Tract Disease
Eligibility Criteria
Inclusion Criteria:
- Subject has severe and heterogeneous emphysema with severe dyspnea
- Subject certified to meet the criteria of ATS/ERS guidelines for management of stable COPD
- Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m
- Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study
Pulmonary Function Testing Results (PFT's) demonstrate:
- FEV1 ≤ 45% of predicted
- RV ≥ 150% of predicted
- TLC ≥ 100% of predicted
Exclusion Criteria:
- Patient has a BMI < 15 kg/m2
Arterial Blood Gas Level (ABG) indicates:
- PCO2 > 55 mm Hg
- PO2 < 45 mm Hg on room air
- Subject has a diffuse emphysema pattern
- Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day
- Subject has an active asthma (>15 mg of prednisone daily)
- Giant bulla (> 1/3 volume of lung)
- Pulmonary hypertension
- Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections
Sites / Locations
- Sparks Regional Medical Center
- Kaiser Permanente Riverside Medical Center
- University of California San Diego
- California Pacific Medical Center
- Mayo Clinic Jacksonville
- Miami VA Healthcare System
- Sarasota Memorial Hospital
- Tampa General Hospital
- Piedmont Hospital
- University of Chicago
- Northwestern Memorial Hospital
- Louisiana State University Hospital
- University of Maryland
- Beth Israel Deaconess Medical Center
- Lahey Clinic
- Beaumont Botsford Hospital (DCRC)
- Cooper University Hospital
- Cornell NYPH
- Carolinas Medical Center
- University of Cincinnati
- Kaiser Permanente Northwest Medical Center
- Penn State Milton S. Hershey Medical Center
- Temple University Hospital
- University of Pittsburgh Medical Center
- University of Tennessee Medical Center
- Vanderbilt University Medical Center
- UT Southwestern Medical Center at Dallas
- Michael DeBakey VA Medical Center
- University of Utah
- Fletcher Allen Medical Center
- Virginia Commonwealth University
- Medical College of Wisconsin
- University of Calgary
- Laval University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Spiration Valve System
Spiration Valve System, α-1
Medical Management
Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management.
α-1 antitrypsin deficiency subjects will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management. There is no randomization for this group.
The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.