A Multicenter, Randomized, Single-blind, Sham-controlled Clinical Trial to Evaluate the Safety and Effectiveness of Targeted Lung Denervation Radiofrequency Ablation Devices in the Treatment of Chronic Obstructive Pulmonary Disease
The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.
• Participants aged ≥40 and ≤ 85 years;
• Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC\<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1\<30%pred, PaCO2≤50mmHg;
• CAT ≥ 10 or mMRC ≥2;
• Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;
• Recent participation in a formal pulmonary rehabilitation program should have occurred ≥3 months prior to consent; if participants are currently enrolled in a maintenance program, they should agree to continue their current program through their 12-month follow-up visit;
• Documented history of taking standard medication (consistent with GOLD guideline\<2022\>) for ≥12 months at the time of consent;
• Received an influenza vaccine within the 12 months prior to consent or agrees to obtain an influenza vaccine during the clinical investigation, and agrees to annual influenza vaccines for the duration of the clinical investigation;
• Resting SpO2 ≥ 89% at the time of screening;
• Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary;
⁃ Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.