Long-term Efficacy and Safety Research of Left Bundle Branch Pacing

Completed

• Conditions: Atrioventricular Block; Left Bundle Branch Pacing

• Registration Number: NCT05600699
• Lead Sponsor: Linyi People's Hospital

Brief Summary

Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

Detailed Description

A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2019-12-31
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-30
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study

Exclusion Criteria

• Low rate of pacing, and loss to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in left ventricular ejection fraction at 3 years	Baseline and 3 years	Left ventricular ejection fraction (%)
Change from Baseline in left ventricular end diastolic diameter at 3 years	Baseline and 3 years	Left ventricular end diastolic diameter (ms)
Change from Baseline in left atrium diameter at 3 years	Baseline and 3 years	Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)
Change from Baseline in pulmonary artery systolic pressure at 3 years	Baseline and 3 years	Pulmonary artery systolic pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in threshold at 3 years	Baseline and 3 years	Threshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms
Change from Baseline in impedance at 3 years	Baseline and 3 years	Impedance was measured with a pace-sensing analyser: impedance(Ω)

Trial Locations

Locations (1)

Linyi People's Hospital; 🇨🇳 Linyi, Shandong, China