Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study (LBBAP)

Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.

Study Overview

• Status: Recruiting
• Conditions: Bradyarrhythmia; Pacemaker Syndrome; Biventricular Cardiac Pacemaker Malfunction
• Intervention / Treatment: Device: Left Bundel Area Pacing

Detailed Description

Right ventricular (RV) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. Right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (LV) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. Hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. His bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the RV. However, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of His bundle were the most significant concerns related to this method. Subsequently, left bundle branch area pacing (LBB-AP), first described in 2017 by Huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to His bundle pacing. Recent studies report promising mid-term outcome concerning left ventricular desynchrony. To the best of our knowledge, bi-ventricular activation was never studied in patients with LBB-AP.

Multiple tools have been used to assess biventricular (BiV) synchrony specially with chronic resynchronization therapy (CRT) including echocardiography and 12 lead ECG. Eschalier et al. found that epicardial noninvasive ECG mapping, was better at predicting clinical CRT response than QRS duration or the presence of LBBB. Activation patterns and timings with RV apical pacing, native LBBB, and BiV pacing have been well studied using this tool. With LBBP, however, these activation parameters have not yet been described.

This study aims to evaluate bi-ventricular activation in patients equipped with LBB-AP using non-invasive 3D mapping system in patients with or without baseline ventricular conduction disorder.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie Dubois; Phone Number: +3224763254; Email: aurelie.dubois@uzbrussel.be
• Study Contact Backup: Name: Carlo de Asmundis, MD, PhD; Phone Number: +32024763704; Email: hrmc@uzbrussel.be

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Aurélie Dubois; Phone Number: +3224763254; Email: aurelie.dubois@uzbrussel.be
    • Contact: Carlo de Asmundis, MD, PhD; Email: HRMC@uzbrussel.be

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 30 patients with a functional LBB-AP pacemaker

Exclusion Criteria:

• Age < 18 years
• Previous cardiac surgery
• Cardiomyopathy with documented ventricular scar
• Patients with prior pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Body surface mapping; With the Insite Vest, activation of the epicardium will be performed.	Device: Left Bundel Area Pacing; RV Lead will be placed deep in the interventricular septum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epicardial map	Activation patterns (visual inspection) on non-invasive 3D ECG mapping	1 day
Epicardial map	Activation time (ms) on non-invasive 3D ECG mapping	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echo parameters for resynchronization	LVEF (%)	90 days
Echo parameters for resynchronization	intraventricular delay (ms)	90 days

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Carlo De Asmundis, MD, PhD, UZ Brussels

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): February 21, 2024
• Study Completion (Estimated): October 21, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pacemaker; Wide QRS; Left bundle area pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: EC-2022-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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