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

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

Recruiting
18-90 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Chronic Obstructive Pulmonary Disease

NCT05775588

China-Japan Friendship Hospital

21 March 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

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