Status:
UNKNOWN
Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium
Lead Sponsor:
KU Leuven
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
Detailed Description
The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilatio...
Eligibility Criteria
Inclusion
- Age 40 - 75 years
- Confluent or destructive heterogeneous emphysema on CT
- Smoking cessation for at least 6m (proven by urinary cotinine levels)
- FEV1 \< 60 %predicted, RV \> 150 %predicted, TLC \> 90 %predicted
- RV/TLC ratio ≥ 0.55
- 6MWD \< 450 meter
- mMRC ≥ 2
- Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
- LABA-LAMA bronchodilator therapy as a minimum therapy
- Able to sign informed consent
Exclusion
- Homogenous emphysema
- PaCO2 \> 60 mmHg with ambient air
- PaO2 \< 45 mmHg with ambient air
- Previous LVRS, lung transplantation, lobectomy
- TLCO or FEV1 \< 20% predicted
- Significant pulmonary hypertension (PaPsyst \> 50 mm Hg)
- Heart failure with reduced EF (\< 40%)
- 6MWD \< 100 meter
- BODE index ≥ 7 and eligible for transplantation
- Active cancer
- Life expectancy \< 3 months
- Significant lung disease other than COPD/emphysema
- Unable to comply with study procedures
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03264768
Start Date
August 1 2017
End Date
December 1 2020
Last Update
October 25 2019
Active Locations (1)
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1
UZ Leuven
Leuven, Flanders, Belgium, 3000