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

C

China-Japan Friendship Hospital

Status

Enrolling

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Procedure: Lung volume reduction surgery with endobronchial valve implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05775588
2022-NHLHCRF-LX-01-0202-1

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Lung volume reduction surgery group
Experimental group
Treatment:
Procedure: Lung volume reduction surgery with endobronchial valve implantation

Trial contacts and locations

1

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Central trial contact

Qin Zhang, MD; Mingming Deng, MD

Data sourced from clinicaltrials.gov

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