Status:
UNKNOWN
Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures
Lead Sponsor:
Heidelberg University
Conditions:
Heterogeneous Emphysema
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and comp...
Detailed Description
50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of e...
Eligibility Criteria
Inclusion
- written informed consent
- ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
- severe lung emphysema (FEV1\<45%, RV\>150%, TLC\>100%)
- pO2\>60 mmHg with 4l O2, pCO2 \< 60 mmHg at rest
- heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
- confirmed heterogeneity by YACTA®
- disclosure of parallel channels through relevant interlobar fissures
- age \> 30 years
- stable COPD without exacerbation 8 weeks prior to screening
- dose of cortisone\< 20 mg prednisone or equivalent OCS
- non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
- current CoHb \< 2,5%
Exclusion
- BMI \< 18 mg/kg2
- significant bronchiectasis with sputum production of 4 tablespoons/day
- 6-minute-walk distance \< 150 m
- myocardial infarction within 6 weeks prior screening visit
- decompensated heart failure
- cardiomyopathy with moderate or severe restricted LVF
- long-term medication with Clopidogrel
- status after lung resection (Lobectomy/Pneumonectomy)
- existing pregnancy
- female subjects of child-bearing potential without acceptable forms of contraception
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01902732
Start Date
June 1 2013
Last Update
July 18 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
LungenClinic Grosshansdorf
Großhansdorf, Germany, 22927
2
LungenClinic Grosshansdorf
Großhansdorf, Germany, 22927
3
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
4
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126