Long Term Follow up Investigation of Endobronchial Valves in Emphysema (LIVE)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

Condition or disease	Intervention/treatment
Pulmonary Emphysema	Device: Zephyr Endobronchial Valve (EBV)

Detailed Description:

Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Main cohort; Patients of both genders of at least 18 years of age; Who 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; Treated with Zephyr Endobronchial Valve (EBV)	Device: Zephyr Endobronchial Valve (EBV); • Implantation of at least one Zephyr EBV following Chartis assessment

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. FEV1 [ Time Frame: 2 years ]
   Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures :

1. 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
2. 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)
3. Survival over 5 years [ Time Frame: 5 years ]
   Survival status over the 5 year study period

Other Outcome Measures:

1. Adverse Events [ Time Frame: 5 years ]
   Tabulation of adverse events occuring over the 5 year study period

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient participation is entirely voluntary. Patients must meet the inclusion/exlusion criteria to be eligible for the study.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Heidelberg Hospital
Heidelberg, Germany, D-69126

Sponsors and Collaborators

Pulmonx International Sàrl

Investigators

Principal Investigator:	Felix JF Herth, Prof. Dr.	Medizinische Fakultät Heidelberg

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pulmonx International Sàrl
ClinicalTrials.gov Identifier:	NCT01580215 History of Changes
Other Study ID Numbers:	630-0013
First Posted:	April 18, 2012
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