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COMPARison of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP

COMPARison of procedural outcomes of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000304538
Enrollment
100
Registered
2024-03-22
Start date
2023-11-17
Completion date
2024-05-31
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Left bundle branch pacing (LBBP) is rapidly emerging pacing therapy. Traditionally, lumenless fixed helix lead is used for LBBP which is delivered through a fixed curve or preshaped flexible curve delivery catheter. Left bundle area can also be captured with implantation of traditional stylet-driven leads delivered with the use of various delivery sheaths from different manufacturers. Currently, both techniques are in use; however, data regarding comparison of outcomes of these two different lead systems is limited. This trial aims at comparing the outcomes of these two different techniques of LBBP which are currently in use.

Interventions

Left bundle branch pacing (LBBP) is a rapidly emerging pacing modality. Traditionally, lumenless fixed helix lead is used for LBBP delivered with a fixed curve or preshaped deflectable delivery catheter. However, it can also be done with stylet driven lead when used with appropriate delivery catheter. In this clinical trial one arm will receive lumen less lead and another will receive stylet driven lead for LBBP. No investigational therapy is involved as both methods are tested and currently in

Left bundle branch pacing (LBBP) is a rapidly emerging pacing modality. Traditionally, lumenless fixed helix lead is used for LBBP delivered with a fixed curve or preshaped deflectable delivery catheter. However, it can also be done with stylet driven lead when used with appropriate delivery catheter. In this clinical trial one arm will receive lumen less lead and another will receive stylet driven lead for LBBP. No investigational therapy is involved as both methods are tested and currently in use. Intervention arm will receive stylet driven lead system. LBBP will be performed with stylet driven lead delivered to target location through a delivery catheter. A pre-shaped delivery catheter (such as CPS Locator 3D sheth) will be used which is standard of care. Left bundle capture will be confirmed by paced RBBB morphology plus one of the following. 1. V6-R wave peak time <75 ms in patients with narrow QRS and <80 ms in patients with bundle branch block, 2. V6-V1 inter peak interval of >44 ms, 3. transition from nonselective to selective left bundle branch or left ventricular septal capture. 'Template beat' be used to guide the procedure if induced during lead implantation. Procedure will be performed once and confirmation of left bundle branch capture will be considered acute success. Usual procedural duration is ~1-2 hours. Procedure will be performed by experienced cardiac electrophysiologist specialised in left bundle branch pacing. Another cardiac electrophysiologist will be independently responsible for validating the left bundle branch capture and independent team of cardiac physiologists will be responsible for collecting data regarding procedure start, end and electrocardiographic parameters.

Sponsors

Canberra heart rhythm foundation
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) Age: 18 years and above b) Recipients of left bundle branch pacing therapy

Exclusion criteria

a) Metallic tricuspid valve implant b) Severe tricuspid stenosis c) Complex congenital heart disease, dextrocardia. d) Venous anatomy unsuitable for transvenous pacing - e.g venous stenosis, congenital malformation e) Venous anatomy or any other pathology precluding pacing from left sided vein e) Upgrade from a failed His bundle pacing f) Highly dependent or with mental impairment g) Pregnant women h) Inability to follow up, interstate patients i) Refuse to/unable to give consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026