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.
The study will be a prospective, multi-centre, pilot study aimed to evaluate the effect of VATS fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe COPD who exhibit collateral ventilation. Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia. Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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.
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.
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
St. Vincent's Private Hospital Fitzroy
Fitzroy, Victoria, Australia
Residual Volume (RV)
Absolute Change in Residual Volume (RV) from baseline to 6-months post Zephyr Valve procedure.
Time frame: 6 months
Forced Vital Capacity (FVC)
Absolute change in Forced Vital Capacity (FVC) from baseline to 6-months post Zephyr Valve procedure.
Time frame: 6 months
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.
Time frame: 6 months
Total Lung Capacity (TLC)
Absolute change in Total Lung Capacity (TLC) from baseline to 6-months post Zephyr Valve procedure.
Time frame: 6 months
Six-Minute Walk Test (6MWT)
Absolute change in Six-Minute Walk Test (6MWT) from baseline to 6-months post Zephyr Valve procedure.
Time frame: 6 months
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.
Time frame: 6 months
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.
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Time frame: 6 months
Forced Expiratory Volume in 1 second (FEV1)
Percent change in FEV1 from baseline to 6-months post Zephyr Valve procedure.
Time frame: 6 months