Combined Zephyr Valve System With Inter-lobar Fissure Completion for Lung Volume Reduction in Emphysema (COMPLETE-1)
Emphysema or COPD
About this trial
This is an interventional treatment trial for Emphysema or COPD focused on measuring COPD, Endobronchial valves, Emphysema, Video-assisted thoracic surgery, Robotic thoracic surgery
Eligibility Criteria
Inclusion Criteria:
- Age 40 to 75 years.
- Stable with less than 10mg prednisone (or equivalent) daily.
- Nonsmoking for 4 months prior to screening and willing to not smoke during the study duration.
- Completed a supervised pulmonary rehabilitation program less than equal to 12 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 12 months prior.
- Current pneumococcus vaccination.
- Current influenza vaccination.
- Willing and able to complete protocol required study follow-up assessments and procedures.
Exclusion Criteria:
- > 95% fissure completion on high-resolution chest CT-scan (HRCT) or StratX evaluation with a Chartis evaluation negative for collateral ventilation.
- Clinically significant (greater than 4 tablespoons per day) mucus production.
- Myocardial infarction within 6 months of screening.
- Uncontrolled congestive heart failure.
- Three or more pneumonia episodes in last year.
- Three or more COPD exacerbation episodes in the last year.
- Prior lung transplant, LVRS, bullectomy, or lobectomy.
- Clinically significant bronchiectasis.
- Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.
- Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45mmHg) or evidence or history of CorPulmonale as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (completed within the last 3 months prior to screening visit).
- Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT.
- Post-bronchodilator FEV1 less than 15% or greater than 45% of the predicted value at screening.
- TLC less than 100% predicted (determined by body plethysmography at screening).
- RV less than 150% predicted in patients with heterogeneous emphysema or less than 200% predicted in patients with homogeneous emphysema (determined by body plethysmography at screening).
- DLCO less than 20% of the predicted value at screening.
- Post-rehabilitation 6-minute walk distance less than 100 meters or greater than 450 meters at screening.
- PaCO2 greater than 50mmHg on room air at screening.
- PaO2 less than 45mmHg on room air at screening
Sites / Locations
- Beth Israel Deaconess Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Medical management group
Intervention group
Crossover group
COPD patients with severe emphysema and incomplete lobar fissures will be placed on maximal medical therapy for 3 months. At the end of this 3 month period, patients will fill in an additional set of quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. New pulmonary function testing will be performed and crossover to the intervention group will be offered.
COPD patients with severe emphysema and incomplete lobar fissures will undergo video-assisted thoracic surgery fissure completion and valves placement. After a 3 month follow-up period, patients will fill additional quality of life questionnaires including the St.George Respiratory Questionnaire, COPD Assessment tool, and the modified medical research council dyspnea scale. Pulmonary function testing and a high-resolution CT scan will be performed at the end of the 3-month postoperative follow-up.
Subjects allocated to the medical management group will be offered to crossover after the 3 months follow-up period. The same procedure as in the intervention group will be performed. Follow-up after surgery will be the same as in the intervention group.