Objective
The objective of the CONDUCT-Use study is to evaluate the efficacy of ultrasound delivery of pacing leads deep into the septum. It is hypothesized that using ultrasound alongside fluoroscopy during LBBAP lead implantation will decrease the number of attempts needed and increase safety — reducing septal perforation, cardiac tamponade, lead dislodgement, and lead revisions — while minimizing procedure time and radiation exposure.
Background
Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have aimed at determining which area of the heart is the best option for lead placement. An area in the septum separating the ventricles called the left bundle branch area (LBBA) has been identified as a safe and effective area for lead placement. However, as the LBBA location is in the centre of the heart, it is impossible to see its entire extent using X-ray. Current practice requires x-ray guidance to estimate the location, which takes longer procedure times and higher exposure to radiation for both patients and staff. This study will determine if using ultrasound can improve pacemaker lead implantation to the LBBA — potentially reducing attempts, improving accuracy, shortening procedure time, and reducing radiation exposure.
Study Outcomes
Primary
- Greater than two attempts at lead deployment to successfully achieve LBBAP
- Septal perforation
- Worsening tricuspid regurgitation category
- Development of LV septal pacing during follow-up
Secondary
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Age > 18 years
- Eligible to have a single or dual chamber pacemaker implanted for LBBAP
- Confirmed diagnosis of conduction tissue disease
- Able to understand and provide signed, witnessed written informed consent/assent and comply with protocol requirements
- Good imaging quality determined on routine echocardiography
Exclusion Criteria
- Any medical or psychiatric condition that could jeopardize the participant's ability to participate
- Any acute active malignancy requiring treatment, or life expectancy deemed less than 1 year
- Clinically significant disease that increases risk of bleeding (hematological disorders, dialysis patient)
- History of alcohol or drug use disorder within 12 months of pacemaker implantation
- Hepatic impairment (ALT/AST > 3× ULN and/or total bilirubin > ULN at screening)
- Any clinically significant illness prior to pacemaker implantation
- CRT and ICD implants
- Pregnancy or female of childbearing age (if negative pregnancy test not provided)
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.