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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04465461




Registration number
NCT04465461
Ethics application status
Date submitted
7/07/2020
Date registered
10/07/2020
Date last updated
23/07/2020

Titles & IDs
Public title
Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion
Scientific title
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 VEntilation
Secondary ID [1] 0 0
630-0026-01
Universal Trial Number (UTN)
Trial acronym
COVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Emphysema 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Video-assisted thoracoscopic surgery (VATS) fissure completion
Treatment: Devices - Zephyr Valve insertion

Experimental: Treatment - Patients exhibiting baseline collateral ventilation by Chartis® balloon catheter assessment who undergo video-assisted thoracoscopic surgery (VATS) fissure completion surgery, confirmation of fissure completion by computerized tomography (CT) scan and confirmation of conversion to collateral ventilation negative by Chartis® balloon catheter assessment post VATS surgery and subsequent Zephyr Valve insertion.


Treatment: Surgery: Video-assisted thoracoscopic surgery (VATS) fissure completion
Following Bronchoscopy and Chartis® balloon catheter assessment under general anaesthesia and confirmation of collateral ventilation, a unilateral VATS lobar fissure completion will be undertaken with buttressed staples and Coseal spray intended to eliminate collateral ventilation.

Treatment: Devices: Zephyr Valve insertion
Following fissure completion surgery, subjects confirmed to be collateral ventilation negative will undergo bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Residual Volume (RV) - Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Forced Vital Capacity (FVC) - Absolute change in Forced Vital Capacity (FVC) from baseline to 6-months post Zephyr Valve procedure.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) - Absolute change in FEV1/FVC ratio from baseline to 6-months post Zephyr Valve procedure.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Total Lung Capacity (TLC) - Absolute change in Total Lung Capacity (TLC) from baseline to 6-months post Zephyr Valve procedure.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Six-Minute Walk Test (6MWT) - Absolute change in Six-Minute Walk Test (6MWT) from baseline to 6-months post Zephyr Valve procedure.
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
St. George's Respiratory Questionnaire (SGRQ) Total Score - Absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 6-months post Zephyr Valve procedure. The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Modified Medical Research Council (MMRC) Score - Absolute change in the modified Medical Research Council (MMRC) Score from Baseline to 6-months post Zephyr Valve procedure. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Forced Expiratory Volume in 1 second (FEV1) - Percent change in FEV1 from baseline to 6-months post Zephyr Valve procedure.
Timepoint [7] 0 0
6 months

Eligibility
Key inclusion criteria
1. Subject is willing and able to provide informed consent and to participate in the
study.

2. Subject is = 40 years of age.

3. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD
(Global Initiative for Obstructive Lung Disease (GOLD) classification).

4. Subject has a post bronchodilator 15% = FEV1 = 50%.

5. Subject has Total Lung Capacity (TLC) = 100% predicted.

6. Subject has Residual Volume (RV) = 150% predicted.

7. Subject has a normal dobutamine stress echocardiogram.

8. Subject has sufficient exercise tolerance i.e. 150m = 6MWT = 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 Immunization Schedule Guidelines (updated March 2018).
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 Diffusing capacity for carbon monoxide (DLCO) < 20%.

6. Subject has a history of recurrent clinically significant respiratory infections,
defined as three (3) or more COPD exacerbations requiring hospitalization during the
12 months prior to study enrollment (Informed Consent Form signature page).

7. Subject has severe gas exchange abnormalities as defined by any one of the following:

1. Partial pressure of oxygen (PaO2) < 60 mmHg

2. Partial pressure of carbon dioxide (PaCO2) > 45 mmHg

3. Oxygen saturation (SpO2) < 90% on = 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:

1. Pulmonary nodule = 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/positron emission
tomography (PET)).

2. Radiological picture consistent with active pulmonary infection, e.g. unexplained
parenchymal infiltrate.

3. Giant bullae > 30% of the volume of either lung.

4. Significant interstitial lung disease.

5. Significant pleural disease.

11. Subject's baseline electrocardiogram (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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
St. Vincent's Private Hospital Fitzroy - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pulmonx Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, multi-centre, pilot study aimed to evaluate the effect of Video Assisted
Thoracic Surgery (VATS) fissure completion on the efficacy of endobronchial valve insertion
(Zephyr Valve) in the treatment of subjects with severe Chronic Obstructive Pulmonary Disease
(COPD) who exhibit collateral ventilation.
Trial website
https://clinicaltrials.gov/show/NCT04465461
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Naveed Alam, MD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carla Martins
Address 0 0
Country 0 0
Phone 0 0
650-216-0176
Fax 0 0
Email 0 0
cmartins@pulmonx.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04465461