The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.
The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.
Study Type
OBSERVATIONAL
Targeted Lung Denervation (TLD) procedure.
Change in Quality of Life (QOL)
Changes in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) over time will be assessed. Comparisons will be made to baseline score.
Time frame: 6 months; 12 months; 24 months post-procedure
Changes in Pulmonary Function
Basic spirometry tests including FEV1, FVC, forced impulse oscillometry, nitrogen wash-out measures will be performed per standard of care over time. Comparisons will be made to baseline measures.
Time frame: 6 months, 12 months, 24 months post-procedure
Change in 6-Minute Walk Test
Change in 6MWT over time
Time frame: 6 months, 1 year, 2 years
Respiratory-related Adverse Events
Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data.
Time frame: 24 months
Freedom from Device-related Adverse Events
Device-related adverse events will be collected through 6 months post-procedure. The number of subjects free from a device-related adverse event will be reported.
Time frame: Peri-procedure (within 7 days); 1 month and 6 months
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