Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
Brief Summary: This trial is for men and women between the ages of 40 and 74 who have a confirmed diagnosis of emphysema. The objective of the trial is to determine the safety and effectiveness of the IBV Valve at redirecting airflow from diseased portions of the lung to healthier areas to achieve improvement in disease-related health status.


Options:
A: Inclusion Criteria:

* Heterogeneous emphysema
* Able to obtain a Chartis value during Assessment

Exclusion Criteria:

* Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.
B: Inclusion Criteria:

1. Age: \> 40 and ≤ 75 years old
2. Diagnosis of heterogeneous emphysema with upper lobe predominance
3. FEV1 \< 45% predicted
4. TLC \> 100% predicted
5. RV \> 150% predicted
6. 6-minute walk test \> 140 meters
7. mMRC ≥ 2 (mMRC)
8. Non-smoking for 3 months
9. Optimized medical management and completed pulmonary rehabilitation

Exclusion Criteria:

1. Known α-1-antitrypsin deficiency
2. BMI \< 15 kg/m2 or \> 35 kg / m2
3. History of pneumothorax within previous 18 months
4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
5. Respiratory infections or recurring COPD exacerbations \> 3 hospitalizations in past 12 months or active infection
6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 \< 15% predicted; DLCO \< 20% predicted; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
C: Inclusion Criteria:

* Candidates have mostly upper lobe, severe emphysema.
* Must be able to participate in standard exercise testing.
* Willing to abstain from cigarette smoking for 4 months prior and during the entire trial.
* Willing to participate in a randomized, blinded study and complete the required follow-up visits during the study period.
* Willing to participate in multiple visits to a medical center for health assessment tests.
* Willing to have a minimum of one overnight stay in the hospital.

Exclusion Criteria:

* Evidence of another co-existing major medical disease.
* Unable to tolerate, flexible bronchoscopy procedures.
* Active asthma, chronic bronchitis.
* Diffuse emphysema pattern, alpha 1-antitrypsin deficiency.
* Has had prior lung volume reduction surgery.
D: Inclusion Criteria:

* Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
* Forced expiratory volume in 1 second (FEV1) \< 45% predicted
* Total lung capacity (TLC) \> 100% predicted
* Residual volume (RV) \> 150% predicted
* Post rehabilitation 6 minute walk test \> 140m
* Non-smoking for 4 months

Exclusion Criteria:

* Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
* History of recurrent respiratory infections
* Evidence of large bullae (\>30% of either lung) in a non-target lobe
* FEV1 \< 15% predicted
* Diffusing capacity for carbon monoxide (DLCO) \< 20% predicted

Answer: C