Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

Study Overview
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Brief Summary
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In recent years, the finding of long-term deleterious effects of right ventricular pacing (RVP) has led to an ongoing search for alternative pacing sites such as His bundle stimulation. The depolarization of the ventricles through the His-Purkinje cardiac conduction system seems to represent an ideal physiological approach to ventricular pacing, capable of engaging the normal conduction pathways and determining synchronous ventricular activation. However, there are still no clinical studies that have evaluated the electromechanical functions of the left ventricle with His bundle pacing (HBP) identified after electroanatomical reconstruction with 3D mapping system. Investigators aimed to compare the electromechanical effects on left ventricle of HBP, compared to RVP stimulation and to spontaneous rhythm of each patient.

Detailed Description
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Patients with indication for permanent pacemaker implantation were included in the study. The stimulation lead was positioned at the level of the His bundle after complete electroanatomical reconstruction of the atrium and right ventricle with 3D mapping system; a second backup lead was eventually placed in the right ventricle. Within 24 hours after implantation, each patient underwent 12-lead ECG and a complete echocardiographic examination in the different pacing modalities (HBP, RVP and patient's spontaneous rhythm) focused on the evaluation of biventricular systo-diastolic function, speckle-tracking and myocardial work of the left ventricle.

Official Title
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Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem: EMPATHY Study

Conditions
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Pacemaker DDD, His Bundle Pacing, Right Ventricular Pacing

Intervention / Treatment
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* Other: His Bundle Pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with indication of class I or class IIa for permanent pacemaker implantation, in accordance with the guidelines of the European Society of Cardiology on cardiac pacing Age ≥ 18 years Written consent Exclusion Criteria: Patients unable to express informed consent Pregnancy Severe mitro-aortic valve disease Left ventricular ejection fraction ≤ 35%

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Other: His Bundle Pacing|Pacing of the His bundle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm. | Measurement of QRS width (msec) in 12-lead electrocardiogram | 24 hours after implantation | 
| Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm. | Transthoracic echocardiogram measurement such as left ventricular systolic function (%), left ventricular Global Longitudinal Strain (GLS %), tissue doppler and severity of any valve disease | 24 hours after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D mapping system, Myocardial work, Mechanical dyssynchrony, 12-lead Electrocardiogram, Speckle-tracking echocardiography