Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block

This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy

Study Overview

• Status: Not yet recruiting
• Conditions: Atrio-Ventricular Block

Detailed Description

• Cardiac pacing is an effective therapy for treating patients with bradycardia due to sinus node dysfunction or atrioventricular block. However, traditional right ventricular apical pacing (RVAP) causes electric and mechanical desynchrony, increasing the risk for atrial arrhythmias and heart failure.
• .Cardiac resynchronization therapy(CRT)is another pacing modality employed for treatment of HF .Clinical studies have demonstrated that CRT promotes left ventricular reverse remodelling and reduces morbidity and mortality in patients with HF . Although CRT's benefits are well demonstrated, the therapy has been associated with significantly high non-response rate(30-40%).Also, the BVP is a non-physiological approach that requires two leads to activate the ventricular myocardium and not the specialized conduction system
• Therefore, there is a need to develop a physiological pacing approach that provides synchronized contraction of the ventricles
• Although His bundle pacing (HBP)has been widely used as a physiological pacing modality, it is limited by challenging implantation technique, unsatisfactory success rate in patients with wide QRS wave, high pacing capture threshold, and early battery depletion.
• Recently, the left bundle branch pacing (LBBP), defined as the capture of the left bundle branch (LBB) via trans ventricular septal approach, has emerged as a new physiological pacing modality.
• this approach has been found to provide physiological pacing that guarantees electrical synchrony of the left ventricle with a low pacing threshold.
• LBBP implantation is done by The Select Secure lead (model 3830) and Select Site C315HisorC304His sheaths are used in operation, while an electrophysiological multichannel recorder is used to simultaneously document intracardiac EGMs and 12-lead ECG .the Pacing System Analyzer (PSA) is used to test the pacing parameters and record intracardiac EGMs. The operation process can be summarized as follows: (1) establishment of the venous access and determination of the initial LBBP site; (2) introducing a pacing lead into the right ventricle and screwing it into the interventricular septum(IVS) until it reached in the LBB areas;(3) assessing the lead depth into ventricular septum and confirming LBB capture; (4)removing the sheath and providing the slack; and(5)programming the pulse generator.
• There is a limited number of clinical studies, featuring small sample sizes, that have shown that, compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. Also, there have been limited number of randomized controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB) versus those with RVAP.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University
    • Contact: Karim Mohamed Aly, Assistant lecturer; Phone Number: 00201068545195; Email: karimeltaher294@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

. Patients with AVB who meet indications for pacemaker , with an estimated percentage of ventricular pacing ≥50%

Description

Inclusion Criteria :

• Patients with AVB who meet indications for pacemaker
• Implantation with an estimated percentage of ventricular pacing ≥50%
• Ability to provide informed consent

Exclusion Criteria:

• Failure to cooperate with follow-up.
• Persistent atrial fibrillation.
• Patients with heart failure (LVEF) ≤35%,
• Estimated glomerular filtration rate less than 30 ml/min.
• Septic shock
• advanced malignant tumor.
• Pregnancy or prepared to get pregnant
• Cardiac tamponade or major hemopericardium

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LBB area pacing group; study group with LBB area pacing
RV apical pacing area; study group with RV apical pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effectiveness with LBB pacing	Assess left ventricular global strain using speckle tracking echocardiography (percentage)	3 years
Incidence of adverse events in patient with LBB pacing	Malignant arrhythmia(Yes/No)	3 years
Incidence of septal perforation	Detect septal perforation(Yes/No)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	• All-cause mortality (Yes or No) cardiovascular deaths (Yes or No) rehospitalisation with heart failure (Yes or No) Lead dislocation (Yes or No) Lead infection. (Yes or No)	3 years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Atrioventricular block; LBB area pacing; RV apical pacing
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Atrioventricular Block
• Other Study ID Numbers: LBB pacing vs RV pacing in AVB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes