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Left Bundle Branch Area PacingNCT07882563

Transesophageal Echocardiography in Conductive System Pacing in Pediatric Patients

A study testing Left Bundle Branch Pacing in people with Left Bundle Branch Area Pacing, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Left Bundle Branch Area Pacing
What is being tested?
Left Bundle Branch Pacing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Dec 2026to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Patients will not attend for follow up after implantation.
  • Patients have critical systematic illness which may interfere with cardiac function assessment.
  • Patients have poor echocardiographic window.
  • All patients will be subjected to:
  • 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.
  • Full Physical examination:
Show all 21Show fewer
  • 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).
  • 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.
  • LBBAP implantation technique:
  • -All patients will undergo implantation of permanent pacemaker either single or dual chamber under fluoroscopic guidance according the EHRA procedural recommendations.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Alaa Rashad, Assistant Lecturer contact

01026453282

alaarashad084@gmail.com

Mahmoud Abdelsabour, Professsor contact

01001202779

m_abd_elsabour@aun.edu.eg

About this study

Official title: The Incremental Value of Transesophageal Echocardiography in Conductive System Pacing in Pediatric Patients

  • 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.
Being tested
Left Bundle Branch Pacing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left Bundle Branch PacingProcedure or surgery

    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.

Study groups in NCT07882563
Study groupRoleWhat they receive
Pediatric patients who are indicated for LBBAPOther1. 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.
Receives: Procedure: Left Bundle Branch Pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: half to one hour for each case implantation.

Secondary outcomes (2)
  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).

    Measured: 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.

    Measured: one week to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
* The investigators will select the pediatric cases who have an indications for permanent pacemaker implantation followed contemporary guideline-based recommendations. * All patients will undergo implantation of permanent pacemaker either single or dual chamber under fluoroscopic guidance according the EHRA procedural recommendations with the guidance of (3D-TEE ) for more accurate lead positioning through direct visualization of the interventricular septum.
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882563
Sponsor's protocol ID
LBBAP in Pediatric Patients
Status last verified
Sep 2026
First submitted
1 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Left Bundle Branch Pacing in people with Left Bundle Branch Area Pacing, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alaa Rashad, Assistant Lecturer (01026453282, alaarashad084@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of success of LBBAP procedure with the guidance of intraprocedural 3D-TEE. (time frame: half to one hour for each case implantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07882563, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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