Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial.

ABSTRACT: Rationale: Less invasive, nonsurgical approaches are needed to treat severe emphysema.Objectives: To evaluate the effectiveness and safety of the Spiration Valve System (SVS) versus optimal medical management.Methods: In this multicenter, open-label, randomized, controlled trial, subjects aged 40 years or older with severe, heterogeneous emphysema were randomized 2:1 to SVS with medical management (treatment) or medical management alone (control).Measurements and Main Results: The primary efficacy outcome was the difference in mean FEV₁ from baseline to 6 months. Secondary effectiveness outcomes included: difference in FEV₁ responder rates, target lobe volume reduction, hyperinflation, health status, dyspnea, and exercise capacity. The prim

SUBMITTER: Criner GJ 

PROVIDER: S-EPMC6884033 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature