Comparison of Cardiac Function Between Left Bundle Branch Pacing and Right Ventricular Outflow Tract Septal Pacing in Pacemaker-dependent Patients

May 4, 2022 updated by: Ruiqin xie
Permanent pacemaker implantation is a common method for bradycardia and cardiac conduction dysfunction. With the development of physiological pacing, the optimal location of ventricular pacing site is still improving. Traditional ventricular pacing site at the apex of right ventricle or septum of right ventricular outflow tract（RVOT）, causing iatrogenic left bundle branch block and asynchronous ventricular contraction, leading to cardiac remodeling, pacemaker-mediated cardiomyopathy and congestive cardiac failure. Long-term chronic ventricular pacing can lead to changes in endocardial myocytes and myofibrils and promote fibrosis. Thus, the alternative pacing site, HIS bundle pacing, has been sought later. The safety and feasibility of permanent HIS bundle pacing have been confirmed in patients with various cardiac diseases. However, the shortcomings of high and unstable threshold, long implantation time, low R-wave amplitude and HIS bundle damage during implantation limit the application of HIS pacing especially in patients with infra-Hisian block. Left bundle branch pacing(LBBP) is a new technique evolved from HIS bundle pacing. In 2017, Huang et al[9]reported that LBBP was successfully paced using 3830 leads(Medronic Inc. USA). The advantages of narrow QRS duration, low threshold, high R wave amplitude, easy fixation and correction of left bundle branch block made LBBP more widely used in clinic.However, whether left bundle branch pacing is superior to traditional right ventricular outflow tract septal pacing in cardial function is still lack of sufficient evidence. The purpose of this study is aim to using Brain natriuretic peptide(BNP), echocardiography and speckle-tracking echocardiagraphy, six minutes walk test and quality of life to compare the changes of cardiac function within 1 month between LBBP and RVOP in pacemaker-dependent patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study was to compare the changes of cardiac function within 1month in pacemaker-dependent patients between LBBP and RVOP. A single-center prospective random controlled clinical study was conducted in 60 patients with bradycardia indications. 30 patients underwent RVOP and 30 patients underwent LBBP. The changes of BNP, echocardiogram and speckle-tracking echocardiagraphy, six minutes walk test and quality of life were compared between the two groups before and within 1month. The etiology of pacemaker implantation included high atrioventricular block, atrial fibrillation with slow arrhythmia. Implantation procedures: Left bundle branch pacing was achieved by trans-interventricular septum method in the basal ventricular septum and performed by using the Select pacing 3830 lead(Medtronic Inc, USA) delivered through a fixed sheath(7F C315 HIS, Medtronic Inc, USA). During implantation, a unipolar configuration is used for pacing and recording. The delivery sheath was inserted through left subclavian vein into atrial side of the tricuspid valve to mark His bundle potential under right anterior oblique(20°) fluoroscopic view. As a marker in His bundle region, the sheath with the lead tip was further advanced towards the right side of the ventricular septum approximately 1.5-2cm, and paced QRS morphology showing left bundle branch block(LBBB) at output of 2V/0.4ms. When the sheath with the lead tip screwed to the left side of the septum, paced QRS morphology changed from LBBB to right bundle branch block(RBBB), a gradual change of the notch morphology("W" waveform) in lead V1 gradually shifted and finally disappeared.Another active electrode is implanted in the right auricle.Patients with RVOP: The right ventricular pacing lead was positioned in the low intervals of right ventricular outflow tract, and atrial active lead was positioned at right auricle. BNP was measured routinely before implantation and reexamined on 1 day and 1month after pacemaker implantation.Twelve-lead ECG were recorded including QRS duration, QRS amplitude and QT interval. Echocardiography data were measured by conventional transthoracic echocardiography system including left atrial anteroposterior dimension, left atrial transverse dimension, left atrial vertical dimension, e', peak E-wave velocity, peak A-wave velocity, E/A, E/e', left atrial ejection fraction (LAEF), left ventricular ejection fraction (LVEF), velocity-time integration of aortic blood flow(VTI). Left atrial strain and strain rate were measured by speckle-tracking echocardiography(STE).We also measure the six minutes walk test and quality of life in all patients before and after implantation in 1month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

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

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Second Hospital of Hebei Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pacemaker-dependent patients who agreed to implant a pacemaker.

Description

Inclusion Criteria:

Pacemaker-dependent patients who agreed to implant a pacemaker.

Exclusion Criteria:

Patients with congenital heart diseases, such as atrial septal defect, ventricular septal defect, or rheumatic heart diseases, valvular heart diseases.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Left Bundle Branch Pacing
Device: pacemaker
electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP
Right Ventricular Outflow Tract Septal Pacing
Device: pacemaker
electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in B natriuretic peptide
Time Frame: baseline, 1 day and 1month after implantation
Blood samples are extracted in all patients to detected
baseline, 1 day and 1month after implantation
Changes in Electrocardiograph
Time Frame: baseline, 1 day and 1 month after implantation
QRS duration in ms, QT duration in ms
baseline, 1 day and 1 month after implantation
Changes of the Data of Pacemaker
Time Frame: baseline and 1month after implantation
Threshold value in V, sense in mV of the pacemaker
baseline and 1month after implantation
Changes of Ultrasonic Cardiogram
Time Frame: baseline, 7 days and 1 month after implantation
UCG:sizes of LA in mm
baseline, 7 days and 1 month after implantation
Changes of Ultrasonic Cardiogram
Time Frame: baseline, 7 days and 1 month after implantation
ejection fraction of LV and LA (%)
baseline, 7 days and 1 month after implantation
Changes of six minutes walk test
Time Frame: baseline, 7 days and 1 month after implantation
six minutes walk test in meter.
baseline, 7 days and 1 month after implantation
Changes of quality of life
Time Frame: baseline and 1 month after implantation
SF-36 quality of life test.
baseline and 1 month after implantation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruiqin xie

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XieruiqindoctorLBBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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