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The Impact of Bronchoscopic One-Way Valve Lung Volume Reduction on Right Heart Function in Patients with COPD

The Impact of Bronchoscopic One-Way Valve Lung Volume Reduction on Right Heart Function in Patients with COPD

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091436
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

Experimental group:Deployment of one-way valves

Sponsors

Zhongshan Hospital, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For patients with advanced heterogeneous emphysema, the following criteria and considerations apply: 1. Forced Expiratory Volume in one second (FEV1): 20% to 50% of the predicted value. 2. Total Lung Capacity (TLC): Greater than 100% of the predicted value. 3. Residual Volume (RV): Greater than 175% of the predicted value. 4. 6-Minute Walk Distance (6MWD): Between 100 and 500 meters. Patients with a 6MWD of less than 200 meters should undergo pulmonary rehabilitation before further evaluation. Endobronchial Valve (EBV) Therapy can be considered if high-resolution CT (HRCT) confirms no collateral ventilation between the target lobe and the untreated lobe on the same side. Specific criteria include: • Interlobar Fissure Integrity: • Less than 80%: Procedure not recommended. • Between 80% and 95%: Requires bronchoscopic Charits test. • Greater than or equal to 95%: Indicates no collateral ventilation, allowing for direct procedure or optional Charits test.

Exclusion criteria

Exclusion criteria: Very severe COPD: FEV1 and/or DLco = 20% of the predicted value. • Severe hypercapnia: PCO2 > 60 mmHg on room air. • Severe hypoxemia: PO2 < 45 mmHg on room air. • Presence of collateral ventilation between the target lobe and the untreated lobe on the same side. • Imaging abnormalities in the target lobe, such as interstitial lung disease, potentially malignant lung nodules, or bronchiectasis. • History of myocardial infarction or stroke within the past six months.

Design outcomes

Primary

MeasureTime frame
Echocardiography;Serological biomarkers of cardiac function;

Secondary

MeasureTime frame
Lung function ;Dyspnea and lify quality;

Countries

China

Contacts

Public ContactXiao-Bin Zhang

Zhongshan Hospital, Xiamen University

zhangxiaobincn@xmu.edu.cn+86 159 5927 8266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026