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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pulmonx, Inc. ( Pulmonx International Sàrl )

ClinicalTrials.gov Identifier:

NCT01580215

First received: April 17, 2012

Last updated: October 20, 2015

Last verified: October 2015

History of Changes

Purpose

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

Condition	Intervention
Pulmonary Emphysema	Device: Zephyr Endobronchial Valve (EBV)


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:

FEV1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures:

Modified Medical Research Council (mMRC) Questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Survival status over the 5 year study period

Other Outcome Measures:

Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Tabulation of adverse events occuring over the 5 year study period


Estimated Enrollment:	2000
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Device: Zephyr Endobronchial Valve (EBV) • Implantation of at least one Zephyr EBV following Chartis assessment

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580215

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


Responsible Party:	Pulmonx International Sàrl
ClinicalTrials.gov Identifier:	NCT01580215 History of Changes
Other Study ID Numbers:	630-0013
Study First Received:	April 17, 2012
Last Updated:	October 20, 2015
Health Authority:	Germany: Ethics Commission

Keywords provided by Pulmonx, Inc.:


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

ClinicalTrials.gov processed this record on September 23, 2016

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