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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Pulmonx, Inc.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc. ( Pulmonx International Sàrl )
ClinicalTrials.gov Identifier:
NCT01580215
First received: April 17, 2012
Last updated: March 20, 2013
Last verified: March 2013
  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:


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: July 2019
Estimated Primary Completion Date: July 2016 (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
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
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

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

Contacts
Contact: Felix JF Herth, Prof. Dr. 0049-62-21-396-1200 felix.herth@thoraxklinik-heidelberg.de

Locations
Germany
Heidelberg Hospital Recruiting
Heidelberg, Germany, D-69126
Principal Investigator: Felix JF Herth, Prof. Dr.         
Sponsors and Collaborators
Pulmonx International Sàrl
Investigators
Principal Investigator: Felix JF Herth, Prof. Dr. Medizinische Fakultät Heidelberg
  More Information

No publications provided

Responsible Party: Pulmonx, Inc. ( Pulmonx International Sàrl )
ClinicalTrials.gov Identifier: NCT01580215     History of Changes
Other Study ID Numbers: 630-0013
Study First Received: April 17, 2012
Last Updated: March 20, 2013
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
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014