The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block

NCT ID: NCT06023784

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Left Bundle Branch Area Pacing Right Ventricular Pacing Atrioventricular Block Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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left bundle branch area pacing

Group Type EXPERIMENTAL

left bundle branch area pacing

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

right ventricular pacing

Intervention Type PROCEDURE

Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taibo Chen, PhD.

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Deyan Yang, PhD.

Role: CONTACT

+86 (010)69155068

Facility Contacts

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Taibo Chen, PhD.

Role: primary

+86 (010)69155068

Deyan Yang, PhD.

Role: backup

+86 (010)69155068

Other Identifiers

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the July study

Identifier Type: -

Identifier Source: org_study_id

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