Recruiting

Ultrasound for Pacemakers

Sponsor:

Habib Khan

Code:

NCT06815783

Conditions

Conduction Block, Atrioventricular

Bundle-Branch Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound guidance

Fluoroscopy guided

Study Details

Brief 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.

Conditions

Conduction Block, Atrioventricular

Bundle-Branch Block

Study ID

NCT06815783

Start date

Apr 10, 2025

Status verified date

Oct, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 informed consent/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 malignancy requiring treatment or life expectancy is deemed less than 1 year.
3. Clinically significant 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 ALT/AST >3 × ULN and/or total bilirubin >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).

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Ultrasound guidance

Use of ultrasound in group 2

Fluoroscopy guided

Conventional techniques for implanting LBBAP lead

Primary outcome measure

  • Composite of the Following [ Time Frame: During study procedure and through study completion, an average of 12 months ]

Central Contacts and Locations

Locations

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6G5A5

Contacts

More Information

Sponsor

Habib Khan

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Conduction system pacing
  • Left bundle branch area pacing
  • HIS bundle pacing
  • pacemaker
  • ultrasound
  • NTproBNP
  • EQ5D
  • LVEF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Habib Khan on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.