Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study

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.

Study Overview

• Status: Completed
• Conditions: Atrioventricular Nodal Disease
• Intervention / Treatment: Device: Right ventricular active fixation lead; Device: Left bundle branch pacing lead (Select Secure 3830 lead)

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Rion
    • Patra, Rion, Greece, 26504
      • University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Left Bundle Branch Pacing; Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing	Device: Left bundle branch pacing lead (Select Secure 3830 lead); Implantation of a left bundle branch pacing lead via sheath
Active Comparator: Conventional Right Venticular Pacing; The ventricular lead will be implanted in the right ventricle in the conventional way	Device: Right ventricular active fixation lead; Active fixation lead (standard)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)	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.	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time (min)	The total time required for the completion of the procedure	1 Day of procedure
Fluoroscopy Time (min)	The total time of fluoroscopy	1 Day of procedure
Dose Area Product (DAP) (cGy/cm2)	Total Radiation Dose as expressed with DAP	1 Day of procedure
Implant success	Successful implantation with pacing threshold<2 V	1 Day of procedure
Complications associated with pacemaker implantation	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	through study completion at 1 year post randomisation
B natriuretic peptide measurement (pg/ml)	Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Stroke volume index (SVi) (ml/m2)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Ejection Fraction (EF) (%)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Longitudinal Strain (GLS) (%)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain (%)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain Rate (1/s)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Aortic Time- Velocity Integral (TVI) (cm)	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Work Index (GWI) (mmHg%)	Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Constructive Work (GCW) (mmHg%)	Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Wasted Work (GWW) (mmHg%)	Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the mid septal wall	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the basal lateral wall	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Peak Strain Dispersion (PSD) (msec)	Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in capture threshold (V) in the ventricular lead	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in sense (mV) in the ventricular lead	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	24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Principal Investigator: Georgios Leventopoulos, MD, PhD, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 251/10-05-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No