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

NCT ID: NCT05775588

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung volume reduction surgery group

Group Type EXPERIMENTAL

Lung volume reduction surgery with endobronchial valve implantation

Intervention Type PROCEDURE

the patient would undergo Lung volume reduction surgery with endobronchial valve implantation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lung volume reduction surgery with endobronchial valve implantation

the patient would undergo Lung volume reduction surgery with endobronchial valve implantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gang Hou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mingming Deng, MD

Role: CONTACT

86 18801336854

Qin Zhang, MD

Role: CONTACT

86 18990236167

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gang Hou, Professor

Role: primary

13840065481

Mingming Deng, Doctor

Role: backup

18801336854

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-NHLHCRF-LX-01-0202-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cell Therapy Associated With Endobronchial Valve
NCT04018729 RECRUITING PHASE2/PHASE3