Ultrasound-guided Lead Placement for Left Bundle Branch Area Pacing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares ultrasound guidance with standard fluoroscopy during pacemaker lead placement targeting the left bundle branch area. It aims to determine if ultrasound can reduce the number of lead deployment attempts and improve placement accuracy, potentially lowering radiation exposure to patients and staff. Eligible participants are adults with conduction tissue disease who require LBBAP and have adequate imaging quality on echocardiography. The study considers safety and feasibility in real-world clinical settings across two Ontario centers.

Why it matters

Who can join: the full rules

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).

Where it's running

• London Health Sciences Centre - University Hospital
  London, Ontario, Canada Recruiting
• London Health Sciences Centre
  London, Ontario, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.