Clinical Study of the Pulsed Electric Field Ablation System in Chronic Obstructive Pulmonary Disease

Exclusion Criteria20

• Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
• Patient has a steroid-dependent condition requiring \>10 mg of oral corticosteroid per day.
• Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
• Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, or sinus bradycardia with a heart rate of under than 45 beats per minute, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
• Subject has lung cancer.
• Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
• Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
• Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan as determined by the CT Core Lab.
• Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
• Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
• Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 2 months.
• Patient is unable to walk over 225 meters in 6 minutes.
• Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
• Patient has uncontrolled GERD.
• Patient has known severe pulmonary hypertension (pulmonary artery SP ≥ 50 mmHg).
• Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
• Patient is pregnant, nursing, or planning to get pregnant during study duration.
• Patient is currently participating in another clinical study involving an investigational product.
• Patient is receiving anticoagulation for a cardiovascular indication and, in the Primary investigator's opinion, unable to suspend anticoagulant medications (i.e., aspirin, clopidogrel, warfarin) during bronchoscopy in accordance.
• Patient has known airway colonization with drug-resistant bacteria such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderia cepacia complex, Mycobacterium tuberculosis, Mycobacterium abscessus, Trichoderma, or other significant fungi.