A pilot study of Video Assisted Thoracic Surgery (VATS) fissure completion prior to Zephyr® Endobronchial Valve insertion for severe Chronic Obstructive Pulmonary Disease (COPD) in patients with COllateral VEntilatio

Not Applicable

Active, not recruiting

• Conditions: Chronic COPD; Respiratory - Chronic obstructive pulmonary disease; Surgery - Other surgery

• Registration Number: ACTRN12619000743167
• Lead Sponsor: Pulmonx Australia Pty. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Subject is willing and able to provide informed consent and to participate in the study.
2. Subject is greater than or equal to 40 years of age.
3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (GOLD classification1).
4. Subject has a post bronchodilator FEV1 of greater than or equal to 15% and less than or equal to 50%.
5. Subject has TLC > 100% predicted.
6. Subject has RV > 175% predicted.
7. Subject has a normal dobutamine stress echocardiogram.
8. Subject has sufficient exercise tolerance i.e. 6MWT is greater than or equal to 150m and less than or equal to 450m.
9. Subject has an incomplete lobar fissure i.e. < 90%, as confirmed by CT evaluation of lung fissures.
10. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)
11. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhaemoglobin or cotinine levels.
12. Subject is up to date with preventive vaccinations including seasonal influenza vaccine and pneumococcal vaccine consistent with the Victorian Department of Health and Human Services Immunisation Schedule Guidelines (updated March 2018).

Exclusion Criteria

1. Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form.
2. Subject has an acute COPD exacerbation.
3. Subject has evidence of active respiratory infection.
4. Subject has a post bronchodilator FEV1 < 15%.
5. Subject has a DLCO < 20%.
6. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalisation during the 12 months prior to study enrolment (ICF signature page).
7. Subject has severe gas exchange abnormalities as defined by any one of the following:
a. PaO2 < 60 mmHg
b. PaCO2 > 45 mmHg on room air
c. SpO2 < 90% on less than or equal to 4 L/min supplemental O2 at rest
8. Subject use of systemic steroids > 20mg/day or equivalent and/or immunosuppressive agents in the 4 weeks prior to procedure.
9. Subject unable to temporarily interrupt use of heparins or oral anticoagulants or antiplatelet agents, excluding aspirin.
10. Subject’s pre-operative CT scan indicates the presence of any of the following radiological abnormalities:
a. Pulmonary nodule is greater than or equal to 0.8 cm in diameter (does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET).
b. Radiological picture consistent with active pulmonary infection, e.g. unexplained parenchymal infiltrate.
c. Giant bullae > 30% of the volume of either lung.
d. Significant interstitial lung disease.
e. Significant pleural disease.
11. Subject’s baseline ECG demonstrates clinically significant arrhythmias or conduction abnormalities.
12. Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis.
13. Subject has a known diagnosis of alpha-1 antitrypsin deficiency.
14. Subject is classified as having likely” pulmonary hypertension defined as tricuspid regurgitation velocity > 3.4m/s and/or pulmonary artery peak systolic pressure > 45 mmHg on echocardiogram or a previous formal diagnosis of pulmonary hypertension on right heart catheterization.
15. Subject has suspected significant coronary artery disease defined as regional wall motion abnormalities on dobutamine stress echocardiogram.
16. Subject is classified as being at major cardiac risk with the presence of unstable coronary syndromes (i.e. unstable or severe angina or recent myocardial infarct), decompensated heart failure, significant arrhythmias or severe valvular disease, which warrants intensive management of the condition in accordance with current guidelines on perioperative cardiovascular risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute change from pre-operative baseline at 6 months for Residual Volume (RV) as assessed by plethysmography . [ 6-months post valve implant.]