Atrioventricular Nodal Disease
Conditions
Brief summary
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
Detailed description
In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.
Interventions
DEVICELeft bundle branch pacing lead (Select Secure 3830 lead)
Implantation of a left bundle branch pacing lead via sheath
Active fixation lead (standard)
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age\>18 years old * Patients with atrioventricular block and EF\>50% with a predicted ventricular pacing rate\>20% * Patients with intraventricular septal diameter\>8mm * Written informed consent
Exclusion criteria
* Indication for CRT or ICD device * Patients with no subclavian approach, who are candidates for leadless devices * Presence of severe tricuspid regurgitation * Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time (min) | 1 Day of procedure | The total time required for the completion of the procedure |
| Fluoroscopy Time (min) | 1 Day of procedure | The total time of fluoroscopy |
| Dose Area Product (DAP) (cGy/cm2) | 1 Day of procedure | Total Radiation Dose as expressed with DAP |
| Implant success | 1 Day of procedure | Successful implantation with pacing threshold\<2 V |
| Complications associated with pacemaker implantation | through study completion at 1 year post randomisation | General device related complications: pneumothorax, hemothorax, infection, tamponade, hematoma, lead reoperation Specific complications associated with the left bundle branch pacing procedure: intraventricular septum rupture, septal perforator branch injury with subsequent myocardial infarction or lead displacement |
| B natriuretic peptide measurement (pg/ml) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure |
| Stroke volume index (SVi) (ml/m2) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the SVi will be recorded |
| Ejection Fraction (EF) (%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the EF will be recorded |
| Global Longitudinal Strain (GLS) (%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the GLS will be recorded |
| Left Atrium Strain (%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain will be recorded |
| Aortic Time- Velocity Integral (TVI) (cm) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the aortic TVI will be recorded |
| Global Work Index (GWI) (mmHg%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded |
| Global Constructive Work (GCW) (mmHg%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded |
| Global Wasted Work (GWW) (mmHg%) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded |
| Segmental CW, WW at the mid septal wall | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the mid septal wall will be recorded |
| Segmental CW, WW at the basal lateral wall | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the basal lateral wall will be recorded |
| Peak Strain Dispersion (PSD) (msec) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded |
| Changes in capture threshold (V) in the ventricular lead | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and the potential changes in capture threshold in the ventricular lead will be recorded |
| Changes in sense (mV) in the ventricular lead | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and potential changes in sense in the ventricular lead will be recorded |
| Left Atrium Strain Rate (1/s) | 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure | Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain Rate will be recorded |
Countries
Greece
Outcome results
None listed