NCT05722379

Brief Summary

Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

January 31, 2023

Last Update Submit

February 9, 2023

Conditions

AVB - Atrioventricular Block

Keywords

Left bundle branch pacingRight ventricular pacingMortalitySystolic dyssynchrony

Outcome Measures

Primary Outcomes (3)

  • composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups

    composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups

    through study completion, an average of 2.45 year

  • Lead failure

    reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure

    through study completion, an average of 2.45 year

  • HFH

    HFH was defined as the admission to hospital for \>24 hours with worsening symptoms and signs of heart failure and requiring one or more intravenous diuretics or intravenous inotropic medications

    through study completion, an average of 2.45 year

Secondary Outcomes (3)

  • peri-procedure complication

    through study completion, an average of 2.45 year

  • cardiac death

    through study completion, an average of 2.45 year

  • recurrent unexplained syncope

    through study completion, an average of 2.45 year

Study Arms (1)

high-grade AVB patients undergoing permanent pacemaker implantations

Procedure: left bundle branch pacing (LBBP)Procedure: Right ventricular pacing (RVP)

Interventions

left bundle branch pacing (LBBP)PROCEDURE

After recording the His potential, the 3830-69 lead (Medtronic Inc., Minneapolis, MN USA) was sent 1-2 cm forward and downward to find the insertion point of the right side of intra-ventricular septum combined with the pre-rotation impedance and ECG changes. Ultimately, the tip was perpendicularly straightforward posited against the septum to the left septal side .

high-grade AVB patients undergoing permanent pacemaker implantations
Right ventricular pacing (RVP)PROCEDURE

Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs.

high-grade AVB patients undergoing permanent pacemaker implantations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital

You may qualify if:

  • included consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital

You may not qualify if:

  • patients with pacemaker replacements were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Sichuan, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • Chen Z, Xu Y, Jiang L, Zhang R, Zhao H, Liu R, Zhang L, Li Y, Liu X. Left Bundle Branch Area Pacing versus Right Ventricular Pacing in Patients with Atrioventricular Block: An Observational Cohort Study. Cardiovasc Ther. 2023 Aug 21;2023:6659048. doi: 10.1155/2023/6659048. eCollection 2023.

    PMID: 37645544DERIVED

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhongxiu Chen, Dr

CONTACT

18030708238619087296@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, cardiology department, principal investigator

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 10, 2023

Study Start

January 1, 2023

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

CN(1)