Clinical trial NCT06318130: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes: The LEAD_LBBP Randomized Clinical Trial
Official title: Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pacemaker DDD
Keywords: Left bundle branch pacing
Lead design
Conduction system pacing
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 210
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Fulfil current indications for pacemaker therapy according to international guideline recommendations:

   1. Symptomatic sinus bradycardia/sinus node dysfunction or AV block requiring pacemaker insertion.
   2. Symptomatic heart failure, left ventricular ejection fraction (LVEF) \<35%, left bundle branch block and QRS duration \>120ms.
   3. Symptomatic heart failure, left ventricular ejection fraction (LVEF) \<35%, right bundle branch block and QRS duration \>150ms.
   4. LVEF \<50% with significant anticipated ventricular pacing requirement of ≥20%.
2. Age ≥21 years old
3. Able to provide informed consent
4. Planned LBBP implantation

Exclusion Criteria:

1. Severe tricuspid regurgitation or previous tricuspid valve intervention requiring implantation of left ventricular lead in the coronary sinus.
2. Unable to provide informed consent.
3. Pregnant women.
4. \<21 years of age.

Primary outcomes:
measure: Incidence of loss of left bundle branch capture
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of acute lead failure
timeFrame: 12 months
measure: Serial changes in pacing thresholds (V)
timeFrame: 12 months
measure: Serial changes in R-wave amplitude (mV)
timeFrame: 12 months
measure: Serial changes in lead impedance (ohm)
timeFrame: 12 months
measure: Serial changes in QRS duration (ms)
timeFrame: 12 months
measure: Incidence of peri-procedural complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Heart Centre Singapore
Study officials:
affiliation: NUHS
name: Eugene Tan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: