Bradyarrhythmia
Conditions
Keywords
His Bundle Pacing, Dyssynchrony, Echocardiography, ECG
Brief summary
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
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.
Interventions
Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters acquisition (3) ECG recording
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS duration | Mid-term: 3-6 months after pacemaker implantation | Electrical dyssynchrony Parameter |
| Interventricular mechanical delay | Mid-term: 3-6 months after pacemaker implantation | InterVentricular Mechanical Dyssynchrony Parameter 1 |
| Free-wall-LV-to-RV-delay | Mid-term: 3-6 months after pacemaker implantation | InterVentricular Mechanical Dyssynchrony Parameter 2 |
| Septal-to-posterior wall motion delay | Mid-term: 3-6 months after pacemaker implantation | IntraVentricular Mechanical Dyssynchrony Parameter 1 |
| Opposing wall motion delay | Long term: 12-15 months after pacemaker implantation | IntraVentricular Mechanical Dyssynchrony Parameter 2 |
| systolic dyssynchrony index | Long term: 12-15 months after pacemaker implantation | Ventricular Mechanical Dyssynchrony Parameter 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction | Mid-term: 3-6 months after pacemaker implantation | Global left ventricle function parameter |
| Global longitudinal strain | Mid-term: 3-6 months after pacemaker implantation | Global left ventricle function parameter 2 |
| Left ventricular output track velocity-time integral | Mid-term: 3-6 months after pacemaker implantation | Global left ventricle function parameter 3 |
| Diastolic Filling Time | Mid-term: 3-6 months after pacemaker implantation | Atrioventricular Dyssynchrony Parameter |
| Radial strain | Mid-term: 3-6 months after pacemaker implantation | Additional Ventricular Mechanical Dyssynchrony Parameter 1 |
Countries
Poland