ClinicalTrials.gg
RecruitingNCT06815783CONDUCT USeUpdated Oct 19, 2026

Novel Approach to Conduction System Pacing With Use of Ultrasound

An interventional study of Ultrasound guidance and Fluoroscopy guided in Conduction Block, Atrioventricular and Bundle-Branch Block, sponsored by Habib Khan. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Habib Khan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Updated Oct 19, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have been aimed at determining which area of the heart is the best option for lead placement. An area in the septum separating the verticals called the left bundle branch area (LBBA) has previously been identified as a safe and effective area for lead placement. However, as the LBBA location is in the center of the heart, it is impossible to see the entire extent using X-ray. Current practice requires x-ray guidance to estimate the location and pacing parameters to confirm proximity. Implanting in LBBA takes longer procedure times and higher exposure to X-ray radiation for both patients and hospital staff. Over time, radiation poses an increased risk of cancer and other medical issues.

This study will determine if using ultrasound can improve pacemaker lead implantation to the LBBA. Benefits to patients may include fewer attempts and more accuracy in lead deployment, thereby reducing risks and providing improved outcomes. Benefits to healthcare delivery may include reduction in total procedure time, thereby allowing more cases per day to reduce waitlist, and reduced X-ray exposure to staff thereby reducing cumulative effects.

02

Conditions studied

  • Conduction Block, Atrioventricular
  • Bundle-Branch Block

Keywords

  • Conduction system pacing
  • Left bundle branch area pacing
  • HIS bundle pacing
  • pacemaker
  • ultrasound
  • NTproBNP
  • EQ5D
  • LVEF
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 152 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

Habib Khan is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria: Patients meeting the following criteria are eligible for the study:

  1. Male or female ≥18 years of age
  2. Eligible to have a single or dual chamber pacemaker implanted for LBBAP
  3. Confirmed diagnosis of conduction tissue disease
  4. The participant can understand the written /assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements.
  5. Good imaging quality determined on routine echocardiography

Exclusion Criteria: Patients will be excluded if any one of the following criteria is met:

  1. Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study.
  2. Any acute active requiring treatment or is deemed less than 1 year.
  3. disease that increases their risk of bleeding (hematological disorders, dialysis patient - anticoagulation does not apply)
  4. History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation.
  5. Hepatic impairment defined as /AST >3 × and/or total >ULN, at Screening.
  6. The participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation
  7. Any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation.
  8. CRT and ICD implants.
  9. Pregnancy or female of childbearing age (if negative pregnancy test not provided).
Terms in these criteria, in plain language(7)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
152 participants (estimated)

Study arms

  • Active comparator
    Conventional

    Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure.

    Device: Fluoroscopy guided

  • Experimental
    US guided

    Patients randomized to this arm will have use of ultrasound in venous access and particularly in attempts to place the pacing lead in the septum at the region of LBBA. This will allow the lead to be directly visualized as it is being passed deep into the septum without perforation and it ensure that the lead is perpendicular to the septum.

    Device: Ultrasound guidance

Interventions

  • DeviceUltrasound guidance

    Use of ultrasound in group 2

  • DeviceFluoroscopy guided

    Conventional techniques for implanting LBBAP lead

06

What researchers measure

Primary outcomes

  1. Composite of the Following

    1. Greater than two attempts at lead deployment to successfully achieve LBBAP 2. Septal perforation 3. Worsening tricuspid regurgitation category 4. Development of LV septal pacing during follow-up

    Time frame: During study procedure and through study completion, an average of 12 months

Secondary outcomes

  1. Total Procedure Time

    Time frame: During procedure

  2. Total Radiation Dose

    Time frame: During procedure

  3. Change of LBBAP pacing parameters

    Threshold @ 0.4ms pulse width, sensing, impedance

    Time frame: From procedure to 1 week

  4. Change of LBBAP pacing parameters

    Threshold @ 0.4ms pulse width, sensing, impedance

    Time frame: From procedure to 1 year

  5. Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec)

    Time frame: Through study completion, an average of 12 months

  6. LVEF Improvement

    Time frame: From baseline to 12 months

  7. Patient Satisfaction

    Time frame: Through study completion, an average of 12 months

  8. Differences in Quality of Life - EQ5D

    Time frame: From baseline to 12 months

  9. Amount of Tricuspid Regurgitation

    Measured in mmHg

    Time frame: Through study completion during echocardiography studies, an average of 12 months

  10. Change in NTproBNP

    Time frame: From baseline to 12 months

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Feb 2028, 34 months after the start.

Of 44 interventional studies with no phase under Atrioventricular Block, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 34 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2024
First posted
Feb 7, 2025
StartActual
Apr 10, 2025
Primary completionEst.
Feb 28, 2028
CompletionEst.
Feb 28, 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Recruiting
changed Oct 19, 2026
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • London Health Sciences Centre - University Hospital · London, Canadano status→Recruiting
  • London Health Sciences Centre · London, Canadano status→Recruiting
Oct 19, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • London Health Sciences Centre - University Hospital · London, CanadaContact added h•••@lhsc.on.ca · •••3746
  • London Health Sciences Centre · London, CanadaContact added s•••@lhsc.on.ca · •••6808
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Active, not recruiting→Recruiting
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • London Health Sciences Centre - University Hospital · London, Canadano status→Recruiting
    • London Health Sciences Centre · London, Canadano status→Recruiting
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • London Health Sciences Centre - University Hospital · London, CanadaContact added h•••@lhsc.on.ca · •••3746
    • London Health Sciences Centre · London, CanadaContact added s•••@lhsc.on.ca · •••6808
    + 2 other changes: index terms and verification date

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 ↗

10

Registry details

Key details

Study ID
NCT06815783
Lead sponsor
Habib Khan
Collaborators
Academic Medical Organization of Southwestern Ontario
Responsible party
Habib Khan (Assistant Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Sponsor-investigator
First posted
Feb 7, 2025
Start date
Apr 10, 2025
Primary completion
Feb 28, 2028 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Oct 19, 2026

Oversight

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

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