Ultrasound Guidance for Heart Block

(CONDUCT USe Trial)

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Habib Khan

Disqualifiers: Malignancy, Bleeding disorders, Hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ultrasound can make pacemaker lead placement in the heart safer and more effective. Typically, x-rays guide the pacemaker leads, often resulting in longer procedures and increased radiation exposure. Ultrasound may allow doctors to pinpoint the exact spot in the heart for lead placement, potentially reducing both procedure time and radiation risks. The study seeks individuals who need a pacemaker due to conduction tissue disease and have good imaging quality from routine heart scans. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future pacemaker procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that using ultrasound for pacemaker lead implantation is safe?

Studies have shown that conduction system pacing, like the method used in this trial, is generally safe for patients. Research indicates that this approach can help avoid some risks linked to traditional pacing methods, such as reducing the chance of developing heart problems caused by pacing.

Reports on the safety of conduction system pacing, which includes using ultrasound guidance, show that it doesn't increase the risk of hospital visits for heart issues. This suggests that using ultrasound to guide the placement of pacemaker leads in the heart is well-tolerated. Although the trial itself doesn't specify safety details, testing this approach suggests confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound guidance for heart block treatment because it offers a new way to place pacing leads more precisely. Unlike conventional methods that rely on X-rays and fluoroscopy, ultrasound allows doctors to directly visualize the lead as it is placed into the heart's septum, reducing the risk of perforation. This technique could improve the accuracy of lead placement and potentially enhance the effectiveness and safety of heart pacing procedures.

What evidence suggests that using ultrasound for pacemaker lead implantation to the LBBA could be effective?

Research has shown that using ultrasound to place pacemaker leads increases accuracy and safety. In this trial, participants in the "US guided" arm will benefit from ultrasound guidance during the procedure. Studies have found that conduction system pacing, particularly in the left bundle branch area (LBBA), yields better results than traditional methods. Specifically, it can reduce the risk of death or hospitalization for heart failure. Ultrasound enables doctors to see the exact placement of the lead, resulting in fewer attempts and reduced risk. This may lead to shorter procedures and less radiation exposure for patients. Overall, early evidence suggests that using ultrasound for this procedure is a promising approach. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with various types of heart block, such as Bundle-Branch Block and Atrioventricular Block. It's specifically looking at those who need pacemaker lead placement in the left bundle branch area (LBBA) of the heart. The study aims to include individuals who can benefit from a potentially safer and more accurate implantation method using ultrasound instead of X-rays.

Inclusion Criteria

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

I am eligible for a pacemaker implant for left bundle branch area pacing.

Exclusion Criteria

CRT and ICD implants

Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study

History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo pacemaker lead implantation using either ultrasound guidance or conventional x-ray methods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of tricuspid regurgitation and pacing parameters

12 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Novel Approach to Conduction System Pacing with Use of Ultrasound

Trial Overview The trial is testing whether using ultrasound guidance for pacemaker lead implantation into the LBBA is better than the traditional fluoroscopy (X-ray) guided method. It seeks to determine if ultrasound can reduce procedure time, improve accuracy, decrease radiation exposure, and ultimately provide better patient outcomes.

How Is the Trial Designed?

Group I: US guided Experimental Treatment 1 Intervention

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.

Group II: Conventional Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Habib Khan

Lead Sponsor

Trials

4

Recruited

520+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

Citations

1. acc.org acc.org/Latest-in-Cardiology/Articles/2023/01/18/16/35/Clinical-Outcomes-of-Conduction-System-Pacing

Clinical Outcomes of Conduction System Pacing ... CSP was associated with greater reduction in clinical outcomes of death or HFH compared to BVP in patients with left bundle branch block (LBBB).

2. jacc.org jacc.org/doi/abs/10.1016/j.jacc.2025.06.043

Clinical Outcomes of Conduction System Pacing vs Right ... The aim of this study was to compare the clinical outcomes between RV septal pacing (RVsP) and CSP. Methods. A randomized controlled trial (RCT) was performed ...

3. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02777-8/abstract

Conduction system pacing for the prevention and cure of ... Conduction system pacing compared with biventricular pacing for cardiac resynchronization therapy in patients with heart failure and mildly ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X23003912

State-of-the-Art Review Cardiac Conduction System Pacing The aim of this review is to provide a comprehensive update on recent advances in conduction system pacing.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06815783

Novel Approach to Conduction System Pacing With Use of ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225322/

Outcomes of Conduction System Pacing for Cardiac ... On Kaplan Meier analysis, there was no statistically significant difference in the time to first heart failure hospitalization (log rank P=0.78) and overall ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02871-6/fulltext

Safety and performance of conduction system pacing The purpose of this study was to characterize the safety and performance of HBP and LBBAP among patients enrolled in the Medtronic product surveillance ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.123.012014?doi=10.1161/CIRCEP.123.012014

Real-World Performance of Conduction System Pacing ... Conduction system pacing offers an alternative to RVP that can reduce the risk of pacing-induced cardiomyopathy and heart failure symptoms.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735109725069864

Clinical Outcomes of Conduction System Pacing vs Right ... Patients with atrioventricular (AV) block receiving right ventricular (RV) pacing are at risk of pacing-induced cardiomyopathy (PICM), need for ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04749836

Outcomes and Safety of Various Conduction System ... In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing ...