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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06023784
Other study ID # the July study
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date December 31, 2030

Study information

Verified date July 2023
Source Peking Union Medical College Hospital
Contact Deyan Yang, PhD.
Phone +86 (010)69155068
Email swallow_sums@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 530
Est. completion date December 31, 2030
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Procedure:
left 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.
right 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.

Locations

Country Name City State
China Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of new-onset atrial fibrillation within two years after device implantation
Secondary all-cause mortality within two years after device implantation
Secondary hospitalization for heart failure within two years after device implantation
Secondary an device upgrade for heart failure within two years after device implantation
Secondary alteration of quality of life score within two years after device implantation
Secondary Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography within two years after device implantation
Secondary pacemaker-associated cardiomyopathy within two years after device implantation
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