Long Term Follow up Investigation of Endobronchial Valves in Emphysema (LIVE)
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ClinicalTrials.gov Identifier: NCT01580215 |
Recruitment Status
:
Terminated
(Inability to reach desired recruitment goal; Sponsor executed other RCTs)
First Posted
: April 18, 2012
Last Update Posted
: December 26, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Pulmonary Emphysema | Device: Zephyr Endobronchial Valve (EBV) |
Study Type : | Observational |
Actual Enrollment : | 628 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Long Term Follow up Investigation of Endobronchial Valves in Emphysema |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | September 2016 |

Group/Cohort | Intervention/treatment |
---|---|
Main cohort
|
Device: Zephyr Endobronchial Valve (EBV)
• Implantation of at least one Zephyr EBV following Chartis assessment
|
- FEV1 [ Time Frame: 2 years ]Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
- Modified Medical Research Council (mMRC) Questionnaire [ Time Frame: 5 years ]Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score
- COPD Assessment Test (CAT) [ Time Frame: 5 years ]Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)
- Survival over 5 years [ Time Frame: 5 years ]Survival status over the 5 year study period
- Adverse Events [ Time Frame: 5 years ]Tabulation of adverse events occuring over the 5 year study period

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients of both genders of at least 18 years of age
- Understand and voluntarily sign an informed consent form.
- FEV1 > 15% predicted and < 45% predicted
- RV >180% predicted
- Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System
Exclusion Criteria:
• Active pulmonary infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580215
Germany | |
Heidelberg Hospital | |
Heidelberg, Germany, D-69126 |
Principal Investigator: | Felix JF Herth, Prof. Dr. | Medizinische Fakultät Heidelberg |
Responsible Party: | Pulmonx International Sàrl |
ClinicalTrials.gov Identifier: | NCT01580215 History of Changes |
Other Study ID Numbers: |
630-0013 |
First Posted: | April 18, 2012 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
Keywords provided by Pulmonx, Inc. ( Pulmonx International Sàrl ):
Valves Endobronchial Endoscopic lung volume reduction Pulmonx |
Zephyr Chartis Emphysema COPD |
Additional relevant MeSH terms:
Emphysema Pulmonary Emphysema Pathologic Processes Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |