Mechanical and Electrical Dyssynchrony During His-Bundle Pacing Versus His-Bundle Area Right Ventricular Pacing

Study Overview
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Brief Summary
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The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.

Detailed Description
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Permanent His Bundle Pacing (HBP) is a well-known method of cardiac pacing which is increasingly used in everyday practice. After lead implantation in His Bundle area (HBA) capture of various tissues can be achieved: A. right ventricular myocardium near to HBP; B. cardiac conduction system selectively or nonselectively (with concomitant regional myocardium activation). The different excitability and refractory periods decide which tissue, myocardium or/and the conduction system is effectively paced. A lot of clinical trials revealed the advantage of HBP over apical ventricular pacing (AVP). HBP improves clinical (NYHA, quality of life, hospitalization rate) and echocardiographic (left ventricular dimension and ejection fraction) indicators of heart failure. We are going to compare mechanical and electrical synchrony during the various type of myocardium activation: HBP (nsHBP or sHBP), RV pacing near HBA and native heart rhythm (if possible) in each patient recruited to the study. Adequate pacemaker programming will allow achieving different activations as shown above. The mechanical synchrony will be estimated by transthoracic echocardiography and the electrical one by the detailed analysis of ECG.

Official Title
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Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing

Conditions
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Bradyarrhythmia

Intervention / Treatment
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* Other: Device Programming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively) Exclusion Criteria: not willing or incapable to give written informed consent; previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Device Programming|Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interventricular mechanical delay | InterVentricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | 
| Interventricular mechanical delay | InterVentricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | 
| Free-wall-LV-to-RV-delay | InterVentricular Mechanical Dyssynchrony Parameter 2 | Mid-term: 3-6 months after pacemaker implantation | 
| Free-wall-LV-to-RV-delay | InterVentricular Mechanical Dyssynchrony Parameter 2 | Long term: 12-15 months after pacemaker implantation | 
| Septal-to-posterior wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | 
| Septal-to-posterior wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | 
| Opposing wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 2 | Long term: 12-15 months after pacemaker implantation | 
| Opposing wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 2 | Mid-term: 3-6 months after pacemaker implantation | 
| systolic dyssynchrony index | Ventricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | 
| systolic dyssynchrony index | Ventricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | 
| QRS duration | Electrical dyssynchrony Parameter | Mid-term: 3-6 months after pacemaker implantation | 
| QRS duration | Electrical dyssynchrony Parameter | Long term: 12-15 months after pacemaker implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial strain | Additional Ventricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | 
| Radial strain | Additional Ventricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | 
| Left Ventricular Ejection Fraction | Global left ventricle function parameter | Mid-term: 3-6 months after pacemaker implantation | 
| Left Ventricular Ejection Fraction | Global left ventricle function parameter | Long term: 12-15 months after pacemaker implantation | 
| Global longitudinal strain | Global left ventricle function parameter 2 | Mid-term: 3-6 months after pacemaker implantation | 
| Global longitudinal strain | Global left ventricle function parameter 2 | Long term: 12-15 months after pacemaker implantation | 
| Left ventricular output track velocity-time integral | Global left ventricle function parameter 3 | Mid-term: 3-6 months after pacemaker implantation | 
| Left ventricular output track velocity-time integral | Global left ventricle function parameter 3 | Long term: 12-15 months after pacemaker implantation | 
| Diastolic Filling Time | Atrioventricular Dyssynchrony Parameter | Mid-term: 3-6 months after pacemaker implantation | 
| Diastolic Filling Time | Atrioventricular Dyssynchrony Parameter | Long term: 12-15 months after pacemaker implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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His Bundle Pacing, Dyssynchrony, Echocardiography, ECG