Atrial Fibrillation, Atrioventricular Block, Left Bundle Branch Area Pacing, Right Ventricular Pacing
Conditions
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.
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of new-onset atrial fibrillation | within two years after device implantation |
Secondary
| Measure | Time frame |
|---|---|
| hospitalization for heart failure | within two years after device implantation |
| an device upgrade for heart failure | within two years after device implantation |
| all-cause mortality | within two years after device implantation |
| Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography | within two years after device implantation |
| pacemaker-associated cardiomyopathy | within two years after device implantation |
| alteration of quality of life score | within two years after device implantation |
Countries
China
Contacts
Primary ContactDeyan Yang, PhD.
Outcome results
None listed