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RecruitingNCT06023784Updated Sep 21, 2026

The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block

An interventional study of left bundle branch area pacing and right ventricular pacing in Left Bundle Branch Area Pacing, Right Ventricular Pacing and Atrioventricular Block, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Left Bundle Branch Area Pacing
  • Right Ventricular Pacing
  • Atrioventricular Block
  • Atrial Fibrillation
03

In context

Atrioventricular Block

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

This study's planned enrollment of 530 is above the median of 127 across 78 interventional studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

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

04

Who can participate

Ages eligible
18 Years to 85 Years
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

  • 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 > 300ms;
  • Signed ;

Exclusion criteria

Exclusion Criteria:

  • Baseline echocardiographic assessment of patients with impaired LV function (\<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.
Terms in these criteria, in plain language(3)

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

05

Study design

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

Study arms

  • Experimental
    left bundle branch area pacing

    Procedure: left bundle branch area pacing

  • Active comparator
    right ventricular pacing

    Procedure: right ventricular pacing

Interventions

  • Procedureleft bundle branch area pacing

    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.

  • Procedureright ventricular pacing

    Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

06

What researchers measure

Primary outcomes

  1. the incidence of new-onset atrial fibrillation

    Time frame: within two years after device implantation

Secondary outcomes

  1. all-cause mortality

    Time frame: within two years after device implantation

  2. hospitalization for heart failure

    Time frame: within two years after device implantation

  3. an device upgrade for heart failure

    Time frame: within two years after device implantation

  4. alteration of quality of life score

    Time frame: within two years after device implantation

  5. Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography

    Time frame: within two years after device implantation

  6. pacemaker-associated cardiomyopathy

    Time frame: within two years after device implantation

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    Recruiting
    • Taibo Chen, PhD. · Contact+86 (010)69155068
    • Deyan Yang, PhD. · Contactswallow_sums@163.com · +86 (010)69155068
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 Sep 2023 (actual). Primary completion is estimated for Dec 2028, 63 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 63 months is above that.

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

Registered
Aug 24, 2023
First posted
Sep 5, 2023
StartActual
Sep 30, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2030
Last update
Sep 21, 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 Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06023784
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Sep 5, 2023
Start date
Sep 30, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 21, 2026

Study contacts

Deyan Yang, PhD.
Contact
swallow_sums@163.com
+86 (010)69155068
Taibo Chen, PhD.
study chair · Peking Union Medical College Hospital

Oversight

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

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