Comparing two types of pacing leads for heart pacing outcomes
Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
This study is testing which of two different types of heart pacing leads works better and is safer for people who need left bundle branch pacing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06318130 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the performance of two different pacing lead designs during left bundle branch pacing (LBBP) to determine which leads provide better outcomes. It is a single-blind, randomized controlled trial conducted across three major hospitals in Singapore, involving independent electrophysiologists experienced in LBBP. The study aims to recruit 210 patients and will compare the extendable helix, stylet-driven pacing lead (SDL) against the fixed helix, lumenless pacing lead (LLL) in terms of lead performance and safety. Key metrics include the incidence of lead failure, pacing characteristics, and the safety profile during implantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who require pacemaker therapy for specific heart conditions and can provide informed consent.
Not a fit: Patients with severe tricuspid regurgitation or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients requiring pacemaker therapy by optimizing lead selection during LBBP implantation.
How similar studies have performed: Previous studies have indicated varying success rates with different pacing lead designs, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Singapore
- National University Heart Centre Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Eugene Tan, MBBS — Nuhs
- Study coordinator: Eugene Tan, MBBS
- Email: esjtan@nus.edu.sg
- Phone: +6567795555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.