Clinical trial NCT06023784: The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Left Bundle Branch Area Pacing
Right Ventricular Pacing
Atrioventricular Block
Atrial Fibrillation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 ECG \> 300ms;
* Signed informed consent;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the incidence of new-onset atrial fibrillation
timeFrame: within two years after device implantation
Secondary outcomes:
measure: all-cause mortality
timeFrame: within two years after device implantation
measure: hospitalization for heart failure
timeFrame: within two years after device implantation
measure: an device upgrade for heart failure
timeFrame: within two years after device implantation
measure: alteration of quality of life score
timeFrame: within two years after device implantation
measure: Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
timeFrame: within two years after device implantation
measure: pacemaker-associated cardiomyopathy
timeFrame: within two years after device implantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taibo Chen, PhD.
role: STUDY_CHAIR
References: