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Not yet recruitingNCT06674967Updated Nov 5, 2024

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

An observational study in Atrio-Ventricular Block, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Atrio-Ventricular Block

Keywords

  • Efficacy
  • Safety
  • RV apical pacing
  • LBB area pacing
  • Atrioventricular block
03

In context

Atrioventricular Block

117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.

This study's planned enrollment of 42 is below the median of 300 across 37 observational studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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%

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Failure to cooperate with follow-up.
  • Persistent atrial fibrillation.
  • Patients with heart failure () ≤35%,
  • Estimated less than 30 ml/min.
  • Septic shock
  • advanced malignant tumor.
  • Pregnancy or prepared to get pregnant
  • Cardiac tamponade or major hemopericardium
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • LBB area pacing group

    study group with LBB area pacing

  • RV apical pacing area

    study group with RV apical pacing

06

What researchers measure

Primary outcomes

  1. effectiveness with LBB pacing

    Assess left ventricular global strain using speckle tracking echocardiography (percentage)

    Time frame: 3 years

  2. Incidence of adverse events in patient with LBB pacing

    Malignant arrhythmia(Yes/No)

    Time frame: 3 years

  3. Incidence of septal perforation

    Detect septal perforation(Yes/No)

    Time frame: 3 years

Secondary outcomes

  1. 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)

    Time frame: 3 years

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06674967
Lead sponsor
Assiut University
Responsible party
Karim Mohamed Eltaher Abdelrahman Aly (Assistant lecturer, Assiut University) — Principal investigator
First posted
Nov 5, 2024
Start date
Nov 30, 2024 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Nov 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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