Novel Approach to Conduction System Pacing With Use of Ultrasound

Not Applicable

Active, not recruiting

• Conditions: Conduction Block, Atrioventricular; Bundle-Branch Block

• Registration Number: NCT06815783
• Lead Sponsor: Habib Khan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-07
• Study Start: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13
• Primary Completion: 2028-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total Procedure Time	During procedure
Total Radiation Dose	During procedure
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

Trial Locations

Locations (2)

London Health Sciences Centre - University Hospital; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada