Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

Study Overview
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Brief Summary
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Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

Detailed Description
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Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.

Official Title
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Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Leadless pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients consent to LP implantation surgery Exclusion Criteria: Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava; Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system; Patients with myocardial infarction; Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves; cannot understand or are unwilling to give informed consent.
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

| Intervention/Treatment |
| --- |
|Device: Leadless pacemaker|To observe the effect of pacemaker implantation at different sites on cardiac synchronization and tricuspid regurgitation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of cardiac electrical synchrony | the QRS duration after pacing | 1 month | 
| The evaluation of cardiac mechanical synchrony | ①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond. ②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond，left pre-ejection interval(LPEI) in millisecond. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age may affect synchronization | Age in years | 1 month | 
| BMI may affect synchronization | BMI in kg/m^2 | 1 month | 
| Blood pressure may affect synchronization | Systolic and diastolic blood pressure in mmHg | 1 month | 
| The pacemaker sensing may affect synchronization | pacemaker sensing in millivolt | 1 month | 
| The pacemaker lead impedance may affect synchronization | lead impedance in ohm | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leadless pacing, Synchronization