Atrioventricular BlockNOVEL IINCT07464041
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
A study testing Left Bundle Branch Area Pacing and Right venticular pacing in people with Atrioventricular Block and Left Bunde Branch Area Pacing, run by Samsung Medical Center at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing
- What is being tested?
- Left Bundle Branch Area Pacing and Right venticular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 29 Apr 2024to 18 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator
- Left ventricular ejection fraction ≤50%
- Indication for cardiac resynchronization therapy
- Life expectancy ≤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)
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Samsung Changwon Hospital
Changwon
Samsung Medical Center
Seoul, Seoul, 06351
Veterans Health Service Medical Center
Seoul
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
About this study
Official title: Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial
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.
- Being tested
- Left Bundle Branch Area Pacing, Right venticular pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Bundle Branch Area PacingDevice
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.
Right venticular pacingDevice
Conventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block.
| Study group | Role | What they receive |
|---|---|---|
| Left bundle branch area pacing | Experimental | Left bundle branch area pacing performed using a stylet-driven extendable screw-in lead for treatment of atrioventricular block. Receives: Device: Left Bundle Branch Area Pacing |
| Right ventricular pacing | Active comparator | Conventional right ventricular pacing using a transvenous pacing lead for treatment of atrioventricular block. Receives: Device: Right venticular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV ejection fraction
% at echocardiography
Measured: at 1 years after PPM implantation
Secondary outcomes (6)
all cause death
incidence (%)
Measured: at 1 years after PPM implantation
Cardiac death
incidence (%)
Measured: at 1 years after PPM implantation
HF admission
incidence (%)
Measured: at 1 years after PPM implantation
Lead dislodgement
incidence (%)
Measured: at 1 years after PPM implantation
T wave alternans
during 24 holter monitoring
Measured: at 1 years after PPM implantation
NTproBNP
pg/mL
Measured: at 1 years after PPM implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start29 Apr 2024
- Primary completion18 Aug 2027 (estimated)
- Study completion18 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Jung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464041
- Sponsor's protocol ID
- SMC-2023-07-102
- Other IDs
- FF091
- Acronym
- NOVEL II
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07464041
- Acronym / sponsor ID
- NOVEL II / SMC-2023-07-102
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 18 Aug 2027 (estimated)
- Study completion
- 18 Aug 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left bundle branch area pacing | Experimental | Device: Left Bundle Branch Area PacingLeft bundle branch area pacing performed using a stylet-driven extendable screw-in lead for treatment of atrioventricular block. |
| Right ventricular pacing | Active comparator | Device: Right venticular pacingConventional right ventricular pacing using a transvenous pacing lead for treatment of atrioventricular block. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (4 listed)
- Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator
- Left ventricular ejection fraction ≤50%
- Indication for cardiac resynchronization therapy
- Life expectancy ≤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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Bundle Branch Area PacingLeft bundle branch area pacing performed using a stylet-driven extendable screw-in pacing lead to achieve physiological ventricular activation in patients with atrioventricular block. | Device | Left bundle branch area pacing |
| Right venticular pacingConventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block. | Device | Right ventricular pacing |
Primary outcome
LV ejection fraction
Time frame: at 1 years after PPM implantation
% at echocardiography
6 secondary outcomes
all cause death
Time frame: at 1 years after PPM implantation
Cardiac death
Time frame: at 1 years after PPM implantation
HF admission
Time frame: at 1 years after PPM implantation
Lead dislodgement
Time frame: at 1 years after PPM implantation
T wave alternans
Time frame: at 1 years after PPM implantation
NTproBNP
Time frame: at 1 years after PPM implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Bundle Branch Area Pacing and Right venticular pacing in people with Atrioventricular Block and Left Bunde Branch Area Pacing, run by Samsung Medical Center at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV ejection fraction (time frame: at 1 years after PPM implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.