Status:
NOT_YET_RECRUITING
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Left Bundle Branch Area Pacing
Right Ventricular Pacing
Eligibility:
All Genders
18-85 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT06023784
Start Date
September 30 2023
End Date
December 31 2030
Last Update
September 5 2023
Active Locations (1)
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1
Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730