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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06023784

Collaborator

(none)

530

Enrollment

Location

Arms

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Bundle Branch Area Pacing Right Ventricular Pacing Atrioventricular Block Atrial Fibrillation	Procedure: left bundle branch area pacing Procedure: right ventricular pacing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

530 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: left bundle branch area pacing	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.
Active Comparator: right ventricular pacing	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.

Arm

Intervention/Treatment

Experimental: left bundle branch area pacing

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.

Active Comparator: right ventricular pacing

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.

Outcome Measures

Primary Outcome Measures

the incidence of new-onset atrial fibrillation [within two years after device implantation]

Secondary Outcome Measures

all-cause mortality [within two years after device implantation]
hospitalization for heart failure [within two years after device implantation]
an device upgrade for heart failure [within two years after device implantation]
alteration of quality of life score [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Chair: Taibo Chen, PhD., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT06023784

Other Study ID Numbers:

the July study

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Atrioventricular Block

Study Results

No Results Posted as of Sep 5, 2023