5 results
The purpose of this study is to assess the safety and effectiveness of bronchoscopic lung volume reduction (BLVR) using the PulmonxEndobronchial Valve (EBV) in treated study participants compared to control participants to support a premarket…
Verification of number of mode switches, Verification of undersensing of AFor other ATAs. Incidence of mode switches due to FFRW oversensing using Accent pacemaker in the most sensitive sensing setting(s)using the Optisense vrs Tendril lead
To investigate both the clinical and economical(-healthcare evaluation) improvement of BVR using best responder criteria in patients with severe COPD.
Primary objective:To evaluate pulmonary function (FEV1) at 3 months following placement of Zephyr endobronchial valves in subjects with homogeneous emphysema.Secondary objectives:Evaluation of quality of life, exercise capacity, dyspnea incl. BODE,…
Part A - CX-2009 Monotherapy: Every 21-Day Dosing RegimenThe primary objective of Part A is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the dose-limiting toxicities(DLTs) of CX-…