Left Bundle Branch vs Right Ventricular Pacing for Heart Block

Overseen By Fiorella Rafti, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: ICD, Mechanical valve, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 36 months

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals with heart block, a condition that disrupts the heart's regular rhythm. Researchers compare two heart pacing methods: right ventricular pacing and left bundle branch pacing (using the Select Secure 3830 lead), which may better mimic the heart's natural electrical signals. The aim is to determine if left bundle branch pacing can reduce the risk of heart problems often associated with traditional pacing. Individuals with heart block who require frequent ventricular pacing and have adequate heart pump function might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance heart pacing methods for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these pacing techniques are safe for heart block patients?

Research has shown that left bundle branch pacing (LBBP) is generally safe and helps maintain heart function effectively. It better preserves the heart's pumping strength compared to right ventricular pacing. The SelectSecure 3830 lead, used for LBBP, has performed well for many patients, though some may require adjustments or replacements over time.

Long-term studies on right ventricular pacing have identified risks, such as lead breakage or displacement. It can also lead to more heart problems for some individuals.

Both pacing methods have their advantages and disadvantages. LBBP shows promise for maintaining heart health, while right ventricular pacing has been linked to more complications. Always consult a doctor to determine the best option for individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about left bundle branch pacing for heart block because it offers a more natural way to synchronize the heart's pumping action compared to traditional right ventricular pacing. Most current treatments for heart block use right ventricular pacing, which can lead to less efficient heart function over time. Left bundle branch pacing, on the other hand, directly stimulates the heart's natural conduction system, potentially improving heart performance and reducing the risk of heart failure. This novel approach could lead to better long-term outcomes for patients with heart block.

What evidence suggests that this trial's treatments could be effective for heart block?

Research has shown that left bundle branch pacing (LBBP), one of the treatments studied in this trial, could be a promising option for patients with heart block. Studies have found that LBBP lowers the risk of heart failure and issues with the heart's left side compared to right ventricular pacing, the other treatment arm in this trial. LBBP more closely mimics the heart's natural electrical signals, helping it pump more efficiently. In contrast, right ventricular pacing has been linked to a higher risk of heart problems, such as heart muscle disease and irregular heartbeat. Clinical evidence supports LBBP as a potentially safer and more effective method to maintain heart health. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of heart block who need a lot of ventricular pacing and have an ejection fraction over 35%. It's not for those needing a defibrillator, with mechanical tricuspid valves, previous similar device attempts, pregnant women, permanent atrial fibrillation patients or those with short life expectancy.

Inclusion Criteria

I need a pacemaker and have a severe heart block.

Your heart's ejection fraction is more than 35%.

You have a specific type of heart block called third degree AV block.

Exclusion Criteria

You have a tricuspid valve that was replaced with a mechanical one.

You need an implantable device to help with heart rhythm problems.

I have permanent atrial fibrillation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either left bundle branch pacing or standard right ventricular pacing

36 months

Echos at baseline, 12, 24, and 36 months; NTproBNPs at baseline and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Left bundle branch pacing lead (Select Secure 3830 lead)
• Right ventricular active fixation lead

Trial Overview

The study compares two pacemaker leads: one that paces the left bundle branch (mimicking natural heart rhythm) versus standard right ventricular pacing. The goal is to see if the new method can reduce negative effects on heart function caused by traditional pacing.

How Is the Trial Designed?

Group I: left bundle branch pacing Experimental Treatment 1 Intervention

Group II: Right ventricular pacing Active Control 1 Intervention

Left bundle branch pacing lead (Select Secure 3830 lead) is already approved in European Union, United States for the following indications:

Approved in European Union as Select Secure 3830 Lead for:

• Heart failure
• Cardiac resynchronization therapy
• Left ventricular dysfunction

Approved in United States as Select Secure 3830 Lead for:

• Heart failure
• Cardiac resynchronization therapy
• Left ventricular dysfunction

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

In a study involving 50 bradycardia patients, the Medtronic SelectSecure™ MRI SecureScan™ Model 3830 lead used for left bundle branch area pacing (LBBAP) required an average of 2.1 attempts and 13 rotations for successful placement, indicating that LBBAP implants are more complex than standard pacing procedures.

Bench testing showed that even under extreme simulated conditions, the 3830 lead demonstrated a predicted 10-year conductor fracture rate of only 0.02%, suggesting high reliability and safety for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. Zou, J., Chen, K., Liu, X., et al.[2023]

In a study of 40 patients with heart failure and left bundle branch block, left bundle branch pacing (LBBP) showed a significantly greater improvement in left ventricular ejection fraction (LVEF) compared to biventricular pacing (BiVP) after 6 months, with a mean difference of 5.6%.

LBBP also resulted in greater reductions in left ventricular end-systolic volume and NT-proBNP levels, indicating better heart function and reduced heart failure markers, while showing comparable improvements in other functional measures to BiVP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Left Bundle Branch vs Biventricular Pacing for Cardiac Resynchronization Therapy. Wang, Y., Zhu, H., Hou, X., et al.[2022]

Left bundle branch pacing (LBBP) is effective for patients with heart failure and a left ventricular ejection fraction (LVEF) of 35% or less, particularly those with a widened QRS complex.

Bi-bundle pacing can correct the iatrogenic incomplete right bundle branch block (iRBBB) caused by LBBP, potentially leading to a further reduction in QRS duration and improvement in LVEF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent Bi-Bundle Pacing in a Patient With Heart Failure and Left Bundle Branch Block. Vezi, B., Akinrimisi, OP.[2023]

In a study of 21 patients with heart failure and left bundle branch block, left bundle branch pacing (LBBP) showed greater improvements in electrical and mechanical synchrony compared to biventricular pacing (BVP), including a significant reduction in QRS duration and area.

LBBP also resulted in a higher increase in hemodynamic performance, as measured by the maximum rate of left ventricular pressure rise (dP/dtmax), indicating it may be a more effective option for cardiac resynchronization therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Liang, Y., Wang, J., Gong, X., et al.[2022]

Left bundle branch pacing (LBBP) has a high success rate of 96.8%, but septal perforation occurred in 14.1% of patients, which can be identified using specific unipolar impedance measurements.

When septal perforation is detected during the procedure, it can be managed effectively through reimplantation, and it does not lead to adverse outcomes, as shown by the absence of lead dislodgment in patients during a follow-up period of nearly 10 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological characteristics of septal perforation during left bundle branch pacing. Ponnusamy, SS., Basil, W., Vijayaraman, P.[2022]

Left bundle branch pacing (LBBP) is a promising new method for pacemaker implantation that allows for low and stable pacing thresholds and faster left ventricular activation, which can improve heart function.

The procedure can be safely performed in most patients needing pacemaker therapy, but further standardization and long-term studies are necessary to fully establish its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to implant left bundle branch pacing lead in routine clinical practice. Chen, K., Li, Y.[2020]

A visualization-enhanced technique for left bundle branch pacing (LBBP) implantation significantly reduced procedural time and fluoroscopy duration compared to the standard approach, with times of 66.76 minutes and 7.83 minutes respectively versus 85.46 minutes and 11.11 minutes.

The visualization technique also resulted in fewer lead deployment attempts and a higher success rate in recording left bundle branch potentials (79.3% vs 46.4%), indicating improved efficacy in achieving optimal lead placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced image-guided lead deployment for left bundle branch pacing. Liu, X., Niu, HX., Gu, M., et al.[2022]

Bilateral bundle branch area pacing (BBBP) was successfully performed in 22 out of 36 patients, showing a significant reduction in QRS duration compared to left bundle branch pacing (LBBP), indicating more synchronized ventricular activation.

BBBP not only resolved right bundle branch block morphology in 18 patients but also improved right ventricular activation times, demonstrating its potential for more physiological pacing compared to LBBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Bundle Branch Area Pacing to Achieve Physiological Conduction System Activation. Lin, J., Chen, K., Dai, Y., et al.[2020]

A right-sided approach for left bundle branch area pacing (LBBAP) was successfully performed in a heart failure patient using a modified delivery sheath, demonstrating that LBBAP can be adapted for right-sided implantation.

This case highlights the feasibility of LBBAP in patients with anatomical challenges, such as a persistent left superior vena cava, and suggests that with proper modifications, effective pacing can be achieved with stable parameters in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right-sided approach to left bundle branch area pacing combined with atrioventricular node ablation in a patient with persistent left superior vena cava and left bundle branch block: a case report. Prolič Kalinšek, T., Žižek, D.[2022]

Left bundle branch pacing (LBBP) is a promising alternative to traditional right ventricular pacing and His bundle pacing, offering synchronized ventricular contraction and potentially overcoming limitations such as lead stability and early battery depletion.

LBBP has demonstrated safety and low threshold requirements compared to His bundle pacing, making it a viable option for patients with left ventricular dysfunction and recurrent heart failure, although further long-term studies are needed to confirm its clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch pacing. Sundaram, S., Vijayaraman, P.[2020]

In a study of 94 patients over a mean follow-up of 30 weeks, left bundle branch area pacing (LBBAP) using a standard stylet-driven active fixation lead (SDL) showed a high procedural success rate of 96.8%, comparable to the lumen-less lead (LLL) success rate of 90.3%.

The SDL group required significantly fewer lead deployments (2 vs. 4), while both groups maintained low pacing thresholds and had similar complication rates, indicating that SDL may offer a more efficient approach to LBBAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Zwolle experience with left bundle branch area pacing using stylet-driven active fixation leads. Daniëls, F., Adiyaman, A., Aarnink, KM., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8027573/

Clinical outcomes of left bundle branch pacing compared ...

LBBP is associated with reduction in the occurrence of pacing‐induced left ventricular dysfunction and HFH compared to RVAP in patients requiring permanent ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04624763

Protection of Cardiac Function With Left Bundle Branch ...

The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11309990/

Left bundle branch pacing in third-degree atrioventricular ...

A second 3830 lead was implanted to LBBP, and there was an abrupt shortening of Sti-LVAT from 100 ms to 76 ms while the pacing lead advanced ...

4.

medrxiv.org

medrxiv.org/content/10.1101/2024.04.23.24306255v1.full.pdf

Safety and long-term performance of the Medtronic 3830 ...

This study aims to report on long-term outcomes and safety associated with both His Bundle Pacing (HBP) and Left Bundle Branch. Area Pacing ( ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1443950623004705

Consecutive Experience with Left Bundle Branch Area ...

LBBAP appears to be a safe and effective pacing strategy in a wide range of patients with stable medium-term lead performance.

6.

medrxiv.org

medrxiv.org/content/10.1101/2024.04.23.24306255v1.full-text

Safety and long-term performance of the Medtronic 3830 ...

Using the 3830 lead for HBP can result in significantly elevated thresholds, loss of His-bundle capture, and frequent lead revision rates at long-term follow- ...

7.

link.springer.com

link.springer.com/article/10.1007/s10840-025-02070-3

Safety and performance of the Medtronic 3830 lead in His- ...

Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: results from the Geisinger-Rush Conduction System ...

8.

medtronic.com

medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/cardiac-leads/selectsecure-3830-left-bundle-branch-area-pacing-launch-deck.pdf

Model 3830 left bundle branch area pacing indication ...

The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His or in ...

9.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(24)02871-6/fulltext

Safety and performance of conduction system pacing

This study reports on an analysis of bradycardia patients with a pacemaker system implanted with the SelectSecure Model 3830 lead (Medtronic, ...