Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

Conditions
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COPD

Intervention / Treatment
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* Device: Targeted Lung Denervation (TLD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of COPD with 20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator) History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent Patient is a candidate for bronchoscopy Patient agrees to all follow-up and provides written informed consent. Exclusion Criteria: Presence of lung or chest implants (eg. metal stent, valves, coils) Pregnancy Pre-existing pulmonary hypertension Patient has a pacemaker, internal defibrillator, or other implantable electronic device Inappropriate bronchial anatomy for procedure (per CT scan) Previous abdominal surgical procedures on stomach, esophagus or pancreas Previous treatment with TLD Therapy (in same areas) Known allergy to bronchoscopy or general anesthesia medications Inability to tolerate single lung ventilation for at least 2 min, 30 sec Patient has a GCSI score of ≥ 18 at time of screening visit

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TLD Procedure<br>All subjects who are enrolled and meet the eligibility criteria will undergo Targeted Lung Denervation (TLD). TLD is a bronchoscopically-guided, minimally-invasive procedure using the Nuvaira™ Lung Devervation System. The Nuvaira System is intended for the long-term maintenance treatment of airway obstruction associated with COPD. TLD uses radiofrequency (RF) energy to ablate the airway nerve trunks of the vagus nerves that travel parallel to and outside of the main bronchi and into the lungs. Ablation of the nerves opens the airways and makes breathing easier. | Device: Targeted Lung Denervation (TLD)<br>* Targeted Lung Denervation (TLD) procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months; 12 months; 24 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months, 12 months, 24 months post-procedure | 
| Change in 6-Minute Walk Test | Change in 6MWT over time | 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. | 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. | Peri-procedure (within 7 days); 1 month and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted Lung Denervation, TLD