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Clinical Trials/NCT05600699
NCT05600699
Completed
Not Applicable

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

Linyi People's Hospital1 site in 1 country136 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrioventricular Block
Sponsor
Linyi People's Hospital
Enrollment
136
Locations
1
Primary Endpoint
Change from Baseline in left ventricular ejection fraction at 3 years
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
October 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xinhua Li

Deputy director of Cardiology

Linyi People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline in left ventricular ejection fraction at 3 years

Time Frame: Baseline and 3 years

Left ventricular ejection fraction (%)

Change from Baseline in left ventricular end diastolic diameter at 3 years

Time Frame: Baseline and 3 years

Left ventricular end diastolic diameter (ms)

Change from Baseline in left atrium diameter at 3 years

Time Frame: 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

Time Frame: Baseline and 3 years

Pulmonary artery systolic pressure (mmHg)

Secondary Outcomes

  • Change from Baseline in threshold at 3 years(Baseline and 3 years)
  • Change from Baseline in impedance at 3 years(Baseline and 3 years)

Study Sites (1)

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