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Not yet recruitingNCT07882563Updated Oct 20, 2026

Transesophageal Echocardiography in Conductive System Pacing in Pediatric Patients

An interventional study of Left Bundle Branch Pacing in Left Bundle Branch Area Pacing, sponsored by Assiut University. Not yet recruiting. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Assiut University · Not applicable, Interventional, and Other

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study summary

  • The investigatorse will use the guidance of Intraprocedural three-dimensional transesophageal echocardiography (3D-TEE) for Left Bundle Branch Area Pacing (LBBAP) lead implantation in pediatric patients.
  • This is expected to lead to more procedural efficiency, safe lead positioning and better electrical outcomes, also expected to decrease the lead related complications.
Read the detailed description
  • Cardiac pacing in children usually is needed in the setting of congenital atrioventricular block or atrioventricular block after heart surgery.
  • Considering that the pediatric patients usually require high percentages of ventricular stimulation up to 100%.
  • This high percentage is a risk factor for pacing-associated cardiomyopathy in the pediatric population.
  • Left bundle branch area pacing (LBBAP) is one of the emerging conductive system pacing varieties for better physiological cardiac pacing.
  • LBBAP provides excellent pacing parameters with much lower incidence of pacing induced cardiomyopathy.
  • The implantation of pacemakers in children is still challenging due to their smaller body size, continuing growth, with higher rate of lead related complications compared to older patients.
  • Fluoroscopic guided optimal lead position is a challenge in some cases especially children due to previous mentioned reasons.
  • There is no specific data regarding the three-dimensional transesophageal echocardiography (3D-TEE) role in the LBBAP implantation procedure in adults or pediatric patients, so the investigators will investigate whether intraprocedural 3D-TEE can facilitate LBBAP lead implantation, improve procedural efficiency, ensure safe lead positioning, and identify any lead complications during follow-up.
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Conditions studied

  • Left Bundle Branch Area Pacing
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In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 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.

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Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

The study will include patients fulfilling our inclusion criteria.

Inclusion criteria

Inclusion Criteria:

  1. Pediatric patients aged \<18years old.
  2. Congenital complete atrioventricular block, atrioventricular block as a complication after heart surgery, and symptomatic bradycardia associated with channelopathies.
  3. Indications for permanent pacemaker implantation followed contemporary guideline-based recommendations.
  4. Pediatric patients had previous right ventricular lead implantation and deterioration of LV systolic function.

Exclusion criteria

Exclusion Criteria:

  1. Patients will not attend for follow up after implantation.
  2. Patients have critical systematic illness which may interfere with cardiac function assessment.
  3. Patients have poor echocardiographic window.

All patients will be subjected to:

A. Full history taking: including age, sex, history of DM, HTN, history of CHD or any previous cardiac intervention, symptoms of heart failure, dizziness or syncope and history of any previous arrhythmia.

B. Full Physical examination:

  • General examination Systolic and diastolic blood pressure and heart rate assessment.
  • Local Cardiac examination. C. Laboratory investigations: Pre-operative (CBC - INR - Urea - Creatinine - Serum Electrolytes K, Na, Mg).

D. Standard 12 lead ECG. E. Echocardiography (TTE): For cardiac dimensions (IVS thickness, right side dimensions, left ventricular end- systolic and diastolic diameters), LV systolic function, degree of tricuspid regurgitation if present and any other structural abnormality detected.

F. LBBAP implantation technique:

-All patients will undergo implantation of permanent pacemaker either single or dual chamber under fluoroscopic guidance according the EHRA procedural recommendations.

G. Intraprocedural 3D-TEE during implantation:

- 3D-TEE will facilitate accurate lead positioning through direct visualization of the interventricular septum then the investigators will measure interventricular septum (IVS) length, the angle of lead with the IVS, depth of lead in IVS (the distance from lead tip to the RV subendocardial region), the distance from lead tip to the LV subendocardial region, the distance from the lead tip to tricuspid valve annulus and the distance from the lead tip to RV apex.

H. Electrocardiographic features measured during lead implantation:

  • The investigators will measure QRS duration \& morphology and LVAT duration, notice occurrence of LBB potential and/or fixation beats or not, differentiate selective versus non selective pacing during decremental pacing.
  • Also, the investigators will measure lead current of injury COI and impedance during implantation.
  • Calculation of total time of the procedure and fluoroscopic only time.

I. Follow up of the cases:

After one week and then after 3months by:

  • Assessment of programming parameters (threshold, impendence and sensitivity) and ECG features (V6 RWPT, QRS during\& morphology).
  • TTE for detection of lead complications, worsening of tricuspid regurgitation and any change of left ventricular function.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Other
    Pediatric patients who are indicated for LBBAP

    1. Pediatric patients aged \<18years old. 2. Case who have Congenital complete atrioventricular block, atrioventricular block as a complication after heart surgery, and symptomatic bradycardia . 3. Indications for permanent pacemaker implantation followed contemporary guideline-based recommendations. 4. Pediatric patients had previous right ventricular lead implantation and deterioration of LV systolic function.

    Procedure: Left Bundle Branch Pacing

Interventions

  • ProcedureLeft Bundle Branch Pacing

    Implantation of permanent pacemaker either single or dual chamber under fluoroscopic guidance according the EHRA procedural recommendations with add value or 3D-TEE in the implantation procedure.

06

What researchers measure

Primary outcomes

  1. The percentage of success of LBBAP procedure with the guidance of intraprocedural 3D-TEE.

    The investigators will reach the accurate site of the lead implantation in interventricular septum to pace the left bundle branch by the accurate imaging tool (intraprocedural 3D-TEE).

    Time frame: half to one hour for each case implantation.

Secondary outcomes

  1. The rate 'percent' of the lead related complications during follow up of the cases after implantation.

    The participants follow up will be after one week and then after three months to detect the complications by the measurement tool (change in baseline programming pacing threshold in volt).

    Time frame: one week to three months

  2. Assessment of the lead site inside the interventricular septum for the rate 'percent' of lead displacement complications during follow up.

    The measurement tool is transthoracic echocardiography for measurement the lead site in mm inside the interventricular septum and any change in shape of electrocardiogram waves.

    Time frame: one week to three months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chen YT, Lin YS, Yang PW, Chen U, Chen YL, Chen MC, Chen HC. Left bundle branch area pacing decreased the pressure gradient and severity of tricuspid regurgitation compared with right ventricular pacing. J Interv Card Electrophysiol. 2026 Jun;69(4):669-679. doi: 10.1007/s10840-025-02214-5. Epub 2026 Jan 23. PubMed 41575717 ↗
  • Kato H, Yanagisawa S, Shimizu Y, Ota R, Sakurai T, Suga K, Murakami H, Kada K, Tsuboi N, Inden Y, Murohara T. Clinical Outcomes and Electrophysiological Characteristics of Partial Perforation After Left Bundle Branch Area Pacing. JACC Clin Electrophysiol. 2025 Jun;11(6):1279-1289. doi: 10.1016/j.jacep.2025.01.016. Epub 2025 Mar 19. PubMed 40117417 ↗
  • Stempfel S, Tolppanen H, Valiton V, Burri H. Complications with Left Bundle Branch Area Pacing: The Flip Side of the Coin. Heart Int. 2025 Jun 19;19(1):26-30. doi: 10.17925/HI.2025.19.1.3. eCollection 2025. PubMed 40708764 ↗
  • Sharma PS, Vijayaraman P, Burri H. Complications, Troubleshooting and Follow-up for Left Bundle Branch Area Pacing. Arrhythm Electrophysiol Rev. 2025 Sep 1;14:e20. doi: 10.15420/aer.2024.12. eCollection 2025. PubMed 41036383 ↗
  • Burri H, Jastrzebski M, Cano O, Curila K, de Pooter J, Huang W, Israel C, Joza J, Romero J, Vernooy K, Vijayaraman P, Whinnett Z, Zanon F. EHRA clinical consensus statement on conduction system pacing implantation: executive summary. Endorsed by the Asia-Pacific Heart Rhythm Society (APHRS), Canadian Heart Rhythm Society (CHRS) and Latin-American Heart Rhythm Society (LAHRS). Europace. 2023 Apr 15;25(4):1237-1248. doi: 10.1093/europace/euad044. PubMed 37061850 ↗
  • Jedrzejczyk-Patej E, Mazurek M, Kowalski O, Szulik M, Tyc F, Pietruczuk A, Lenarczyk R, Kalarus Z. Left bundle branch area pacing in children: case series. Eur Heart J Case Rep. 2025 Jan 22;9(2):ytaf020. doi: 10.1093/ehjcr/ytaf020. eCollection 2025 Feb. PubMed 39935814 ↗
  • Liu P, Wang Q, Sun H, Qin X, Zheng Q. Left Bundle Branch Pacing: Current Knowledge and Future Prospects. Front Cardiovasc Med. 2021 Mar 23;8:630399. doi: 10.3389/fcvm.2021.630399. eCollection 2021. PubMed 33834042 ↗
  • Erratum. Europace. 2023 Apr 15;25(4):1520. doi: 10.1093/europace/euad098. No abstract available. PubMed 37061849 ↗
  • Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. PubMed 34455430 ↗
  • Nowosielecka D, Dabrowski P, Stefanczyk P, Nowosielecka A, Kutarski A. The use of transesophageal echocardiography for assessment of lead position while identifying left bundle branch signals. Kardiol Pol. 2025;83(2):210-212. doi: 10.33963/v.phj.102980. Epub 2024 Oct 23. No abstract available. PubMed 39440747 ↗
  • Odozynski G, Froemming C Jr, Dos Santos TV, May B, Losso MJ, Zunino M Jr, Costa PB, Damasceno G, Waks JW, d'Avila A, Forno AD. Transesophageal echocardiography versus fluoroscopy-guided left bundle branch area pacing: a comparative study. J Interv Card Electrophysiol. 2026 Jun 8. doi: 10.1007/s10840-026-02367-x. Online ahead of print. PubMed 42258109 ↗
  • Vijayaraman P, Hughes G, Manganiello M, Leri G, Laver A, Sacco K, Mroczka K, Schmidt E, Mascarenhas VH. Intraprocedural transthoracic EChocardiography to facilitate Left Bundle Branch Pacing: EC-LBBP. Heart Rhythm. 2025 Sep;22(9):e746-e753. doi: 10.1016/j.hrthm.2024.12.039. Epub 2024 Dec 31. PubMed 39746387 ↗

Individual participant data

Plan to share: Yes

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07882563
Lead sponsor
Assiut University
Responsible party
Alaa Rashad Ali (Assistant Lecturer of Cardiovascular Medicine, Assiut University) — Principal investigator
First posted
Oct 20, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Alaa Rashad, Assistant Lecturer
Contact
alaarashad084@gmail.com
01026453282
Mahmoud Abdelsabour, Professsor
Contact
m_abd_elsabour@aun.edu.eg
01001202779
Mahmoud Abdelsabour, Professor
study director · Assiut University

Oversight

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

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