Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction

Table 1 Outcome measures

Co-primary efficacy endpoints	Mean % change in FEV₁ and 6 MWT in the treatment group as compared to control group at 180 days post randomization.
Primary safety endpoint	Major Complications Composite at 180 days post randomization.
Secondary efficacy endpoints	Mean absolute change in: - St. George's Respiratory Questionnaire - Maximal work load as measured by cycle ergometry - Daily oxygen requirement - mMRC
Secondary safety endpoints	Complications (type, timing, and severity, including Kaplan-Meier survival analysis) Device-related adverse events during procedure hospitalization Device-related adverse events post discharge

Abbreviations: FEV₁ = forced expiratory volume in one second, 6 MWT = six minute walk test, RV = residual volume, DLco = diffusion of the lung for carbon dioxide, BODE index = body-mass index, airflow obstruction, dyspnea, and exercise capacity index, EBV = endobronchial valve, mMRC = modified Medical Research Council dyspnea scale

ISSN: 1471-2466