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

Pulmonx

Status: Terminated

Conditions: Pulmonary Emphysema

Treatments: Device: Zephyr Endobronchial Valve (EBV)

Study type: Observational

Funder types: Industry

Identifiers

NCT01580215

630-0013

Details and patient eligibility

About

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

Full 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.

Enrollment: 628 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

628 participants in 1 patient group

Main cohort

Description:

* 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)

Treatment:

Device: Zephyr Endobronchial Valve (EBV)