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

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

Study Overview

• Status: Terminated
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 628

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, D-69126
    • Heidelberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1	Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council (mMRC) Questionnaire	Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score	5 years
COPD Assessment Test (CAT)	Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)	5 years
Survival over 5 years	Survival status over the 5 year study period	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Tabulation of adverse events occuring over the 5 year study period	5 years

Collaborators and Investigators

• Sponsor: Pulmonx International Sàrl
• Investigators: Principal Investigator: Felix JF Herth, Prof. Dr., Medizinische Fakultät Heidelberg

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 18, 2012

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Zephyr; Emphysema; Endoscopic lung volume reduction; Valves; Endobronchial; Pulmonx; Chartis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 630-0013