Left Bundle Branch Area PacingNCT06023784
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
A study testing left bundle branch area pacing and right ventricular pacing in people with Left Bundle Branch Area Pacing and Right Ventricular Pacing, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block
- What is being tested?
- left bundle branch area pacing and right ventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2023to 31 Dec 2030
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18-85;
- AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms;
- Signed informed consent;
Who cannot join
- Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
- Patients with the history of atrial fibrillation;
- Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
- Pacemaker replacement without new implanted ventricular electrodes;
- Surgery is required within 1 year due to severe structural heart disease;
- Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);
- AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Taibo Chen, PhD., +86 (010)69155068
Deyan Yang, PhD., +86 (010)69155068, swallow_sums@163.com
About this study
Official title: The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.
- Conditions
- Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation
- Being tested
- left bundle branch area pacing, right ventricular pacing
- Medical subject headings
- Atrioventricular Block, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left bundle branch area pacingProcedure or surgery
Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
right ventricular pacingProcedure or surgery
Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| left bundle branch area pacing | Experimental | Not described Receives: Procedure: left bundle branch area pacing |
| right ventricular pacing | Active comparator | Not described Receives: Procedure: right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of new-onset atrial fibrillation
Measured: within two years after device implantation
Secondary outcomes (6)
all-cause mortality
Measured: within two years after device implantation
hospitalization for heart failure
Measured: within two years after device implantation
an device upgrade for heart failure
Measured: within two years after device implantation
alteration of quality of life score
Measured: within two years after device implantation
Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
Measured: within two years after device implantation
pacemaker-associated cardiomyopathy
Measured: within two years after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start30 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle Branch Area PacingStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taibo Chen, PhD., Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023784
- Sponsor's protocol ID
- the July study
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06023784
- Acronym / sponsor ID
- the July study
- Conditions
- Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Sep 2023 (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.
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.
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 | Procedure: left bundle branch area pacing |
| right ventricular pacing | Active comparator | Procedure: right ventricular pacing |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18-85;
- AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms;
- Signed informed consent;
Key exclusion criteria (7 listed)
- Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
- Patients with the history of atrial fibrillation;
- Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
- Pacemaker replacement without new implanted ventricular electrodes;
- Surgery is required within 1 year due to severe structural heart disease;
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(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration. | Procedure or surgery | left bundle branch area pacing |
| right ventricular pacingRight ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle. | Procedure or surgery | right ventricular pacing |
Primary outcome
the incidence of new-onset atrial fibrillation
Time frame: within two years after device implantation
6 secondary outcomes
all-cause mortality
Time frame: within two years after device implantation
hospitalization for heart failure
Time frame: within two years after device implantation
an device upgrade for heart failure
Time frame: within two years after device implantation
alteration of quality of life score
Time frame: within two years after device implantation
Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
Time frame: within two years after device implantation
pacemaker-associated cardiomyopathy
Time frame: within two years after device 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 21 Sep 2026.
- Individual participant dataSharing planned: No
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Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
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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.
Taibo Chen, PhD. study chair
Peking Union Medical College Hospital
1 site 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 ventricular pacing in people with Left Bundle Branch Area Pacing and Right Ventricular Pacing, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Deyan Yang, PhD. (+86 (010)69155068, swallow_sums@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of new-onset atrial fibrillation (time frame: within two years after device 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 21 Sep 2026.