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
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