Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block

February 9, 2023 updated by: Zhongxiu Chen, West China Hospital

Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. However, clinical studies have shown that RVP can cause electrical and mechanical dyssynchrony of the left ventricle and increase the risks of cardiac insufficiency, atrial fibrillation (AF) and death. 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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Sichuan, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Junyan Zhang
          • Phone Number: 18848242671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with pacemaker replacements were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
high-grade AVB patients undergoing permanent pacemaker implantations
Procedure: left bundle branch pacing (LBBP)
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 .
Procedure: Right ventricular pacing (RVP)
Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
Time Frame: through study completion, an average of 2.45 year
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
Time Frame: through study completion, an average of 2.45 year
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
Time Frame: through study completion, an average of 2.45 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
peri-procedure complication
Time Frame: through study completion, an average of 2.45 year
included pericardial tamponade and pneumothorax
through study completion, an average of 2.45 year
cardiac death
Time Frame: through study completion, an average of 2.45 year
documented arrhythmogenic death, an unexpected presumed pulseles condition with the absence of an obvious noncardiac explanation, or a death due to congestive cardiac failure or structural heart disease
through study completion, an average of 2.45 year
recurrent unexplained syncope
Time Frame: through study completion, an average of 2.45 year
recurrent unexplained syncope
through study completion, an average of 2.45 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2023

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-LBBP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AVB - Atrioventricular Block

Clinical Trials on left bundle branch pacing (LBBP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe