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

NCT06318130 | Active Not Recruiting DMC

• 1 other identifier: LEAD-LBBP
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pacemaker DDD

Keywords

Left bundle branch pacing; Lead design; Conduction system pacing

Outcome Measures

Primary Outcomes (1)

• Incidence of loss of left bundle branch capture

  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.

  12 months

Secondary Outcomes (6)

• Incidence of acute lead failure

  12 months

• Serial changes in pacing thresholds (V)

  12 months

• Serial changes in R-wave amplitude (mV)

  12 months

• Serial changes in lead impedance (ohm)

  12 months

• Serial changes in QRS duration (ms)

  12 months

Study Arms (2)

Fixed helix, lumenless pacing lead (FHL)

ACTIVE COMPARATOR

Lumenless leads used are fixed helix pacing leads (SelectSecure 3830 pacing lead from Medtronic) during the LBBP procedure.

Device: Fixed helix, lumenless pacing lead.

Extendable helix, stylet-driven leads (EHL)

ACTIVE COMPARATOR

Stylet-driven leads used are extendable helix pacing leads (Biotronik Solia S60 lead from Biotronik or Tendril STS pacing lead from St. Jude Medical) during the LBBP procedure.

Device: Extendable helix, stylet-driven pacing lead.

Interventions

Fixed helix, lumenless pacing lead. DEVICE

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

Fixed helix, lumenless pacing lead (FHL)

Extendable helix, stylet-driven pacing lead. DEVICE

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

Extendable helix, stylet-driven leads (EHL)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Heart Centre Singapore

Singapore, Singapore

Location

Study Officials

• Eugene Tan, MBBS

  NUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to the type of pacing lead received. Operators will not be blinded as they will be performing the procedure. Post-procedure, investigators and outcomes assessors will be blinded to the treatment arm during adjudication of outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A target of 210 participants will be enrolled in this study consisting of two groups and randomised in a 1:1 fashion to either of two groups. Group 1: Fixed helix, lumenless pacing lead (FHL) Group 2: Extendable helix, stylet driven pacing lead (EHL)

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 19, 2024
• Study Start: January 1, 2023
• Primary Completion: October 19, 2025
• Study Completion: October 19, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)