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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Atrioventricular Block, Left Bundle Branch Pacing

Intervention / Treatment
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* Device: Cardiac pacemaker and Select Secure lead


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| left bundle branch potential group<br>the left bundle branch potential was recorded at implantation | Device: Cardiac pacemaker and Select Secure lead<br>* model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA<br>|
| Purkinje potential group<br>the purkinje potential was recorded at implantation | Device: Cardiac pacemaker and Select Secure lead<br>* model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA<br>|
| no-potential group<br>no potential was recorded at implantation | Device: Cardiac pacemaker and Select Secure lead<br>* model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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