Conduction Block, AtrioventricularCONDUCT USeNCT06815783

Novel Approach to Conduction System Pacing With Use of Ultrasound

A study testing Ultrasound guidance and Fluoroscopy guided in people with Conduction Block, Atrioventricular and Bundle-Branch Block, run by Habib Khan at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Conduction Block, Atrioventricular, Bundle-Branch Block
What is being tested?: Ultrasound guidance and Fluoroscopy guided
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 2 sitesCanada
Study dates: 10 Apr 2025to 28 Feb 2029
Phase: Interventional

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

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

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

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Canada2 sites, 2 recruiting

London Health Sciences Centre - University Hospital
London, Ontario, N6A5A5
Dr. Habib Khan, 519-663-3746, habib.khan@lhsc.on.ca
Recruiting
London Health Sciences Centre
London, Ontario, N6G5A5
Sara El-Richani, 519-685-8500 ext. 36808, sara.el-richani@lhsc.on.ca
Recruiting

Other trials in Canada

About this study

Official title: Reduction of Radiation and Improving Conduction System Pacing Using Ultrasound (CONDUCT USe)

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.

Conditions: Conduction Block, Atrioventricular, Bundle-Branch Block
Being tested: Ultrasound guidance, Fluoroscopy guided
Keywords: Conduction system pacing, Left bundle branch area pacing, HIS bundle pacing, pacemaker, ultrasound, NTproBNP, EQ5D, LVEF
Medical subject headings: Atrioventricular Block, Bundle-Branch Block

What participants receive

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

Ultrasound guidanceDevice
Use of ultrasound in group 2
Fluoroscopy guidedDevice
Conventional techniques for implanting LBBAP lead

Study groups in NCT06815783
Study group	Role	What they receive
Conventional	Active comparator	Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure. Receives: Device: Fluoroscopy guided
US guided	Experimental	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. Receives: Device: Ultrasound guidance

What is being measured

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

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

Secondary outcomes (10)

Total Procedure Time
Measured: During procedure
Total Radiation Dose
Measured: During procedure
Change of LBBAP pacing parameters
Threshold @ 0.4ms pulse width, sensing, impedance
Measured: From procedure to 1 week
Change of LBBAP pacing parameters
Threshold @ 0.4ms pulse width, sensing, impedance
Measured: From procedure to 1 year
Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec)
Measured: Through study completion, an average of 12 months
LVEF Improvement
Measured: From baseline to 12 months
Patient Satisfaction
Measured: Through study completion, an average of 12 months
Differences in Quality of Life - EQ5D
Measured: From baseline to 12 months
Amount of Tricuspid Regurgitation
Measured in mmHg
Measured: Through study completion during echocardiography studies, an average of 12 months
Change in NTproBNP
Measured: From baseline to 12 months

Timeline

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

10 Apr 202528 Feb 2029

First posted7 Feb 2025
Study start10 Apr 2025
Primary completion28 Feb 2028 (estimated)
Study completion28 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Conduction Block, AtrioventricularStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 152 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06815783
Sponsor's protocol ID: 14539
Acronym: CONDUCT USe
Status last verified: Oct 2026
First submitted: 21 Feb 2024
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Central Haemodynamics and Pacing for AV Block
Atrioventricular Block, Pacing Therapy
Not yet recruiting
LLL vs. SDL for LBBP: A Non-inferiority RCT
Bradycardia, Conduction Block, Atrioventricular

All Conduction Block, Atrioventricular trials