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

Not Applicable

Recruiting

• Conditions: Bradyarrhythmia; Pacemaker Syndrome; Biventricular Cardiac Pacemaker Malfunction
• Interventions: Device: Left Bundel Area Pacing

• Registration Number: NCT05401851
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

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 Timeline

• Study Start: 2022-03-24
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-02
• Status Verified: 2023-05
• Primary Completion: 2024-02-21
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Completion: 2024-10-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Body surface mapping	Left Bundel Area Pacing	With the Insite Vest, activation of the epicardium will be performed.

Primary Outcome Measures

Name	Time	Method
Epicardial map	1 day	Activation time (ms) on non-invasive 3D ECG mapping

Secondary Outcome Measures

Name	Time	Method
Echo parameters for resynchronization	90 days	intraventricular delay (ms)

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussel, Belgium