Clinical trial NCT06815783: Novel Approach to Conduction System Pacing With Use of Ultrasound
Official title: Reduction of Radiation and Improving Conduction System Pacing Using Ultrasound (CONDUCT USe)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Conduction Block, Atrioventricular
Bundle-Branch Block
Keywords: Conduction system pacing
Left bundle branch area pacing
HIS bundle pacing
pacemaker
ultrasound
NTproBNP
EQ5D
LVEF
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2025-02-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Composite of the Following
timeFrame: During study procedure and through study completion, an average of 12 months
Secondary outcomes:
measure: Total Procedure Time
timeFrame: During procedure
measure: Total Radiation Dose
timeFrame: During procedure
measure: Change of LBBAP pacing parameters
timeFrame: From procedure to 1 week
measure: Change of LBBAP pacing parameters
timeFrame: From procedure to 1 year
measure: Left Ventricular Activation using 2D Speckled Tracking LV Strain (TomTec)
timeFrame: Through study completion, an average of 12 months
measure: LVEF Improvement
timeFrame: From baseline to 12 months
measure: Patient Satisfaction
timeFrame: Through study completion, an average of 12 months
measure: Differences in Quality of Life - EQ5D
timeFrame: From baseline to 12 months
measure: Amount of Tricuspid Regurgitation
timeFrame: Through study completion during echocardiography studies, an average of 12 months
measure: Change in NTproBNP
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: