Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function

Study Overview
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Brief Summary
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The goal of this type of study: clinical trial is to evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:evaluate the effect of bronchial valve implantation on cardiac function and skeletal muscle function. Participants will undergo Lung volume reduction surgery with endobronchial valve implantation.

Official Title
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Long-term Effects of Endobronchial Valve Implantation on Cardiac Function and Skeletal Muscle Function in Patients With Lung Volume Reduction Surgery

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Procedure: Lung volume reduction surgery with endobronchial valve implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Chronic Obstructive Pulmonary Disease FEV1 ≤ 45% pred and FEV1/FVC<70% TLC>100% pred and RV>175% pred CAT score≥18 Emphysema damage>50% Complete interlobar fissure >95% based on quantitative analysis of CT measurement No smoking>6 months Sign the informed consent form Exclusion Criteria: PaCO2>8.0 kPa, or PaO2<6.0 kPa 6-minute walk test<160m Obvious chronic bronchitis, bronchiectasis or other infectious pulmonary diseases More than 3 hospitalizations for pulmonary infection in the past 12 months before baseline assessment Previous lobectomy, LVRS or lung transplantation LVEF<45% and or RVSP>50mmHg Anticoagulant therapy that cannot be stopped before surgery Patients with obvious immune deficiency Participated in other lung drug studies within the first 30 days of this study Pulmonary nodules requiring intervention Any disease or condition that interferes with the completion of the initial or subsequent assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung volume reduction surgery group<br> | Procedure: Lung volume reduction surgery with endobronchial valve implantation<br>* the patient would undergo Lung volume reduction surgery with endobronchial valve implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline ventricular volume | cardiac magnetic resonance imaging | Baseline | 
| Ventricular volume （6 months after surgery） | cardiac magnetic resonance imaging | 6 months after surgery | 
| Ventricular volume（12 months after surgery） | cardiac magnetic resonance imaging | 12 months after surgery | 
| Baseline FEV1 | Pulmonary function tests | Baseline | 
| FEV1 （6 months after surgery） | Pulmonary function tests | 6 months after surgery | 
| FEV1（12 months after surgery） | Pulmonary function tests | 12 months after surgery | 
| Baseline left Ventricular Ejection Fractions | Echocardiography | Baseline | 
| Left Ventricular Ejection Fractions （6 months after surgery） | Echocardiography | 6 months after surgery | 
| Left Ventricular Ejection Fractions （12 months after surgery） | Echocardiography | 12 months after surgery | 
| Baseline exercise tolerance | 6-minute walk test | Baseline | 
| Exercise tolerance （6 months after surgery） | 6-minute walk test | 6 months after surgery | 
| Exercise tolerance （12 months after surgery） | 6-minute walk test | 12 months after surgery | 
| Baseline health impairment and quality of life of patients Baseline health impairment and quality of life of patients | St. George's Respiratory Questionnaire | Baseline | 
| Health impairment and quality of life of patients （6 months after surgery） | St. George's Respiratory Questionnaire | 6 months after surgery | 
| Health impairment and quality of life of patients （12 months after surgery） | St. George's Respiratory Questionnaire | 12 months after surgery | 
| Baseline cross sectional area of rectus femoris | Rectus femoris ultrasound | Baseline | 
| Cross sectional area of rectus femoris （6 months after surgery） | Rectus femoris ultrasound | 6 months after surgery | 
| Cross sectional area of rectus femoris （12 months after surgery） | Rectus femoris ultrasound | 12 months after surgery | 
| Baseline mmuscle strength of lower limb | Myometer | Baseline | 
| Mmuscle strength of lower limb （6 months after surgery） | Myometer | 6 months after surgery | 
| Mmuscle strength of lower limb （12 months after surgery） | Myometer | 12 months after surgery |