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Active, Not Recruiting

NCT Number: NCT06815783

Novel Approach to Conduction System Pacing With Use of Ultrasound

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Conduction Block, Atrioventricular Arrhythmias, Cardiac Atrioventricular Block Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients meeting the following criteria are eligible for the study:

  • 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

Exclusion criteria

Patients will be excluded if any one of the following criteria is met:

  • 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).

Treatment and study plan

Ultrasound guidance

Device

Use of ultrasound in group 2

Fluoroscopy guided

Device

Conventional techniques for implanting LBBAP lead

Primary outcomes

  1. Composite of the Following

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

    • 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

Secondary outcomes

  1. Total Procedure Time

    Time frame: During procedure

  2. Total Radiation Dose

    Time frame: During procedure

  3. Change of LBBAP pacing parameters

    Time frame: From procedure to 1 week

    Threshold @ 0.4ms pulse width, sensing, impedance

  4. Change of LBBAP pacing parameters

    Time frame: From procedure to 1 year

    Threshold @ 0.4ms pulse width, sensing, impedance

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

    Time frame: Through study completion, an average of 12 months

  6. LVEF Improvement

    Time frame: From baseline to 12 months

  7. Patient Satisfaction

    Time frame: Through study completion, an average of 12 months

  8. Differences in Quality of Life - EQ5D

    Time frame: From baseline to 12 months

  9. Amount of Tricuspid Regurgitation

    Time frame: Through study completion during echocardiography studies, an average of 12 months

    Measured in mmHg

  10. Change in NTproBNP

    Time frame: From baseline to 12 months

Sponsors and collaborators

Lead sponsor

Habib Khan

Other

Collaborators

  • Academic Medical Organization of Southwestern Ontario

Registry information

Official study title

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

Acronym: CONDUCT USe

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 7, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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