Novel Approach to Conduction System Pacing With Use of Ultrasound (CONDUCT USe)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bundle-Branch Block; Conduction Block, Atrioventricular
• Intervention / Treatment: Device: Fluoroscopy guided; Device: Ultrasound guidance

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Centre - University Hospital
    • London, Ontario, Canada, N6G5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure.	Device: Fluoroscopy guided; Conventional techniques for implanting LBBAP lead
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.	Device: Ultrasound guidance; Use of ultrasound in group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of the Following	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	During study procedure and through study completion, an average of 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Habib Khan
• Collaborators: Academic Medical Organization of Southwestern Ontario

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; NTproBNP; pacemaker; LVEF; EQ5D; Conduction system pacing; Left bundle branch area pacing; HIS bundle pacing
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrioventricular Block; Bundle-Branch Block; Heart Block
• Other Study ID Numbers: 14539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No