Novel Approach to Conduction System Pacing With Use of Ultrasound

NCT06815783 — Not applicable, Recruiting, 152 participants, Habib Khan

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Reduction of Radiation and Improving Conduction System Pacing Using Ultrasound (CONDUCT USe)

Registry	NCT06815783, acronym CONDUCT USe
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	152 (Estimated)
Sponsor	Habib Khan (Other); collaborators: Academic Medical Organization of Southwestern Ontario
Conditions	Conduction Block, Atrioventricular, Bundle-Branch Block
Interventions	Ultrasound guidance, Fluoroscopy guided (Device)
Dates	start 2025-04-10, primary completion 2028-02-28 (estimated), completion 2029-02-28 (estimated), first posted 2025-02-07, last updated 2026-10-19
Locations	2 sites in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Conventional	Active comparator	Device: Fluoroscopy guided	Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure.
US guided	Experimental	Device: Ultrasound guidance	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.

Ultrasound guidance (Device): Use of ultrasound in group 2
Fluoroscopy guided (Device): Conventional techniques for implanting LBBAP lead

+Outcome measures

Primary outcomes

Composite of the Following [During study procedure and through study completion, an average of 12 months]: 1. Greater than two attempts at lead deployment to successfully achieve LBBAP 2. Septal perforation 3. Worsening tricuspid regurgitation category 4. Development of LV septal pacing during follow-up

Secondary outcomes

Total Procedure Time [During procedure]
Total Radiation Dose [During procedure]
Change of LBBAP pacing parameters [From procedure to 1 week]: Threshold @ 0.4ms pulse width, sensing, impedance
Change of LBBAP pacing parameters [From procedure to 1 year]: Threshold @ 0.4ms pulse width, sensing, impedance
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 [Through study completion during echocardiography studies, an average of 12 months]: Measured in mmHg
Change in NTproBNP [From baseline to 12 months]

+Eligibility

Sex: All, ages: 18 Years to any

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).

+Locations (2)

Facility	City	Country	Status
London Health Sciences Centre - University Hospital	London, Ontario	Canada	Recruiting
London Health Sciences Centre	London, Ontario	Canada	Recruiting