Novel Approach to Conduction System Pacing With Use of Ultrasound

NCT06815783 | Active Not Recruiting

• 1 other identifier: 14539
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Composite of the Following

  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

  During study procedure and through study completion, an average of 12 months

Secondary Outcomes (10)

• Total Procedure Time

  During procedure

• Total Radiation Dose

  During procedure

• Change of LBBAP pacing parameters

  From procedure to 1 week

• Change of LBBAP pacing parameters

  From procedure to 1 year

• Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec)

  Through study completion, an average of 12 months

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Normal deployment of left bundle branch area pacing with use of xrays and fluoroscopy. No use of ultrasound in the procedure.

Device: Fluoroscopy guided

US guided

EXPERIMENTAL

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

Interventions

Ultrasound guidance DEVICE

Use of ultrasound in group 2

US guided

Fluoroscopy guided DEVICE

Conventional techniques for implanting LBBAP lead

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age
• Eligible to have a single or dual chamber pacemaker implanted for LBBAP
• Confirmed diagnosis of conduction tissue disease
• The participant can understand the written informed consent/assent, provides signed and witnessed written informed consent/assent, and agrees to comply with protocol requirements.
• Good imaging quality determined on routine echocardiography

You may not qualify if:

• Any medical or psychiatric condition that, in the investigator's opinion, could jeopardize or compromise the participant's ability to participate in the study.
• Any acute active malignancy requiring treatment or life expectancy is deemed less than 1 year.
• Clinically significant disease that increases their risk of bleeding (hematological disorders, dialysis patient - anticoagulation does not apply)
• History of alcohol or drug (other than caffeine) use disorder within 12 months of pacemaker implantation.
• Hepatic impairment defined as ALT/AST \>3 × ULN and/or total bilirubin \>ULN, at Screening.
• The participant has any clinically significant illness, in the opinion of the investigator, prior to their pacemaker implantation
• Any other issues which, in the opinion of the investigator, will make the participant ineligible for study participation.
• CRT and ICD implants.
• Pregnancy or female of childbearing age (if negative pregnancy test not provided).

Sponsors & Collaborators

• Habib Khan: lead
• Academic Medical Organization of Southwestern Ontario: collaborator

Study Sites (2)

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

Location

London Health Sciences Centre

London, Ontario, N6G5A5, Canada

Location

MeSH Terms

Conditions

Atrioventricular Block; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Physicians making the referral for pacing or seeing patients in the future will be masked to whether the patients had ultrasound-guided left bundle branch area pacing. The outcomes assessor will not be aware of whether the patients will be randomized to Group 1 (conventional use of fluoroscopy) or Group 2 (assisted with ultrasound)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 7, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)