Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes

Status Recruiting

Clinical Trial Summary

This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) 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.

Clinical Trial Description

This study is a single-blind, randomised controlled trial, aimed at evaluating the performance of the extendable helix, stylet driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) 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 (FHL vs EHL). 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 FHL and EHL 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 FHL and 25% with EHL. 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 FHL or the EHL 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. ;

Study Design

Related Conditions & MeSH terms

Pacemaker DDD

Clinical Trial Details

NCT number	NCT06318130
Study type	Interventional
Source	National University Hospital, Singapore
Contact	Eugene Tan, MBBS
Phone	+6567795555
Email	esjtan@nus.edu.sg
Status	Recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	June 30, 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes — LEAD-LBP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms