ClinicalTrials.gg
Active, not recruitingNCT07464041NOVEL IIUpdated Jul 28, 2026

Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction

An interventional study of Left Bundle Branch Area Pacing and Right venticular pacing in Atrioventricular Block, Left Bunde Branch Area Pacing and Conduction System Pacing, sponsored by Samsung Medical Center. Active, not recruiting at 4 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Apr 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes. These adverse effects are more pronounced in patients with pre-existing left ventricular dysfunction. To overcome these limitations, left bundle branch area pacing (LBBAP), which directly engages the cardiac conduction system to preserve physiological ventricular activation, has been increasingly adopted in clinical practice.

However, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF ≥50%), evidence demonstrating the long-term clinical superiority of LBBAP over conventional RVP remains limited. As a result, both pacing strategies continue to be used in current practice. This multicenter randomized trial aims to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional RVP in patients with atrioventricular block and preserved ejection fraction.

Read the detailed description

Right ventricular pacing (RVP) has been the conventional pacing strategy for patients requiring permanent pacemaker implantation due to bradyarrhythmias. However, chronic RVP has been shown to induce non-physiological ventricular activation, resulting in ventricular dyssynchrony, an increased incidence of pacing-induced cardiomyopathy, and higher long-term morbidity and mortality. These detrimental effects are particularly evident in patients with impaired baseline cardiac function.

Left bundle branch area pacing (LBBAP) has emerged as an alternative physiological pacing strategy that directly captures the cardiac conduction system, thereby preserving synchronized ventricular contraction. Owing to its favorable electrical and hemodynamic characteristics, LBBAP has been increasingly adopted in contemporary clinical practice. Nevertheless, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF >50%), robust evidence demonstrating the long-term clinical benefits of LBBAP compared with conventional RVP is lacking. Consequently, both pacing strategies are currently used interchangeably in real-world practice.

Two main types of pacing leads are currently used for LBBAP: lumen-less fixed screw leads (LLFS leads) and stylet-driven extendable screw-in leads (SDES leads). Although several studies have compared short-term clinical outcomes between LBBAP and RVP, the majority of these investigations have utilized LLFS leads. Data evaluating LBBAP performed with SDES leads, particularly in comparison with conventional RVP, remain extremely limited.

Therefore, the present multicenter randomized controlled trial is designed to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional right ventricular pacing in patients with atrioventricular block and preserved left ventricular ejection fraction. The findings of this study are expected to provide clinically relevant evidence to guide optimal pacing strategy selection in this patient population.

02

Conditions studied

  • Atrioventricular Block
  • Left Bunde Branch Area Pacing
  • Conduction System Pacing
03

In context

Atrioventricular Block

117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.

This study's enrollment of 200 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients requiring permanent pacemaker implantation for the following indications:

  • Third-degree AV block
  • First- or second-degree AV block with an expected ventricular pacing burden ≥40%
  • Atrial fibrillation with slow ventricular response with an expected ventricular pacing burden ≥40%

Exclusion criteria

Exclusion Criteria:

  • Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator
  • ≤50%
  • Indication for cardiac resynchronization therapy
  • ≤1 year (e.g., patients not eligible for heart transplantation due to end-stage heart failure, patients with DNR orders, those receiving hospice care after refusal of life-sustaining treatment, or patients with terminal cancer not eligible for chemotherapy or radiotherapy)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Left bundle branch area pacing

    Left bundle branch area pacing performed using a stylet-driven extendable screw-in lead for treatment of atrioventricular block.

    Device: Left Bundle Branch Area Pacing

  • Active comparator
    Right ventricular pacing

    Conventional right ventricular pacing using a transvenous pacing lead for treatment of atrioventricular block.

    Device: Right venticular pacing

Interventions

  • DeviceLeft Bundle Branch Area Pacing

    Left bundle branch area pacing performed using a stylet-driven extendable screw-in pacing lead to achieve physiological ventricular activation in patients with atrioventricular block.

  • DeviceRight venticular pacing

    Conventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block.

06

What researchers measure

Primary outcomes

  1. LV ejection fraction

    % at echocardiography

    Time frame: at 1 years after PPM implantation

Secondary outcomes

  1. all cause death

    incidence (%)

    Time frame: at 1 years after PPM implantation

  2. Cardiac death

    incidence (%)

    Time frame: at 1 years after PPM implantation

  3. HF admission

    incidence (%)

    Time frame: at 1 years after PPM implantation

  4. Lead dislodgement

    incidence (%)

    Time frame: at 1 years after PPM implantation

  5. T wave alternans

    during 24 holter monitoring

    Time frame: at 1 years after PPM implantation

  6. NTproBNP

    pg/mL

    Time frame: at 1 years after PPM implantation

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Aug 2027, 39 months after the start.

Of 44 interventional studies with no phase under Atrioventricular Block, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 39 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2026
First posted
Mar 11, 2026
StartActual
Apr 29, 2024
Primary completionEst.
Aug 18, 2027
CompletionEst.
Aug 18, 2029
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07464041
Responsible party
Seung-Jung Park (MD, PhD, Samsung Medical Center) — Principal investigator
First posted
Mar 11, 2026
Start date
Apr 29, 2024
Primary completion
Aug 18, 2027 (estimated)
Completion
Aug 18, 2029 (estimated)
Last update
Jul 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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