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NCT Number: NCT06318130

Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial

This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance.

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Key information

Conditions

Pacemaker Ddd

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Heart Centre Singapore

Singapore

About this study

This study is a single-blind, randomised controlled trial, aimed at evaluating the performance of the extendable helix, stylet driven pacing lead (SDL) compared to the fixed helix, lumenless pacing lead (LLL) during left bundle branch pacing (LBBP). The study is a multicentre study across 3 major hospitals in Singapore, and LBBP performed by independent electrophysiologists experienced in performing LBBP.

The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design (LLL vs SDL). The secondary objectives are to determine if lead design affects frequency of lead failure during implantation, investigate differences in short- and medium-term LBBP parameters on follow-up by lead design, and evaluate differences in safety profile between LLL and SDL in LBBP.

This study aims to recruit a target of 210 patients. A previous retrospective study found a loss of LB capture rate of 9% with LLL and 25% with SDL. A sample size of 170 will be required for a type-1 error rate of 5% and power of 80%. Accounting for a dropout rate of 20%, a total of 210 patients will be recruited (105 per group). Eligible subjects will be randomised to either the LLL or the SDL arm. The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4, stratified by centre, to ensure a final allocation ratio of 1:1.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fulfil current indications for pacemaker therapy according to international guideline recommendations:
  • Symptomatic sinus bradycardia/sinus node dysfunction or AV block requiring pacemaker insertion.
  • Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, left bundle branch block and QRS duration >120ms.
  • Symptomatic heart failure, left ventricular ejection fraction (LVEF) <35%, right bundle branch block and QRS duration >150ms.
  • LVEF <50% with significant anticipated ventricular pacing requirement of ≥20%.
  • Age ≥21 years old
  • Able to provide informed consent
  • Planned LBBP implantation

Exclusion criteria

  • Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.
  • Unable to provide informed consent.
  • Pregnant women.
  • <21 years of age.

Treatment and study plan

Fixed helix, lumenless pacing lead.

Device

Patients will be randomised to the fixed helix, lumenless pacing lead design during LBBP implantation.

Extendable helix, stylet-driven pacing lead.

Device

Patients will be randomised to the extendable helix, stylet-driven pacing lead design during LBBP implantation.

Primary outcomes

  1. Incidence of loss of left bundle branch capture

    Time frame: 12 months

    Loss of LBB capture is defined as the absence of the terminal r/R' complex in V1 during initial threshold interrogations at high pacing outputs and the absence of transitions in paced QRS morphology with decreasing pacing outputs until loss of myocardial capture.

Secondary outcomes

  1. Incidence of acute lead failure

    Time frame: 12 months

    Acute lead failure is defined as defined as structural damage to the pacing lead during implant necessitating the use of a new pacing lead.

  2. Serial changes in pacing thresholds (V)

    Time frame: 12 months

    To compare the differences in pacing thresholds (V) at implant and at 12 months after LBBP implant.

  3. Serial changes in R-wave amplitude (mV)

    Time frame: 12 months

    To compare the differences in R-wave amplitude (mV) at implant and at 12 months after LBBP implant.

  4. Serial changes in lead impedance (ohm)

    Time frame: 12 months

    To compare the differences in lead impedance (ohm) at implant and at 12 months after LBBP implant.

  5. Serial changes in QRS duration (ms)

    Time frame: 12 months

    To compare the differences in QRS duration (ms) at implant and at 12 months after LBBP implant.

  6. Incidence of peri-procedural complications

    Time frame: 12 months

    Complications intraprocedurally and on follow-up will be evaluated, including lead dislodgement, lead fracture during implant, septal perforation, septal vein/arterial injury, pneumothorax, pericardial effusion, wound/pacemaker infection.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes

Acronym: LEAD-LBBP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Jun 6, 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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