Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes

Pacemaker DDD Clinical Trial

— LEAD-LBP  

Official title:

Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318130
• Other study ID #: LEAD-LBP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: National University Hospital, Singapore
• Contact: Eugene Tan, MBBS
• Phone: +6567795555
• Email: esjtan[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pacemaker DDD

Intervention

Device:
• Fixed helix, lumenless pacing lead.
Patients will be randomised to the fixed helix, lumenless pacing lead design during LBBP implantation.
• Extendable helix, stylet-driven pacing lead.
Patients will be randomised to the extendable helix, stylet-driven pacing lead design during LBBP implantation.

Locations

Country	Name	City	State
Singapore	National University Heart Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of acute lead failure	Acute lead failure is defined as defined as structural damage to the pacing lead during implant necessitating the use of a new pacing lead.	12 months
Secondary	Serial changes in pacing thresholds (V)	To compare the differences in pacing thresholds (V) at implant and at 12 months after LBBP implant.	12 months
Secondary	Serial changes in R-wave amplitude (mV)	To compare the differences in R-wave amplitude (mV) at implant and at 12 months after LBBP implant.	12 months
Secondary	Serial changes in lead impedance (ohm)	To compare the differences in lead impedance (ohm) at implant and at 12 months after LBBP implant.	12 months
Secondary	Serial changes in QRS duration (ms)	To compare the differences in QRS duration (ms) at implant and at 12 months after LBBP implant.	12 months
Secondary	Incidence of peri-procedural complications	Complications intraprocedurally and on follow-up will be evaluated, including lead dislodgement, lead fracture during implant, septal perforation, septal vein/arterial injury, pneumothorax, pericardial effusion, wound/pacemaker infection.	12 months