Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block

October 25, 2023 updated by: Georgios Leventopoulos, University Hospital of Patras

Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study

Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

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

In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.

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.
Interventional

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.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
    • Rion
      • Patra, Rion, Greece, 26504
        • University Hospital of Patras

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age>18 years old
  • Patients with atrioventricular block and EF>50% with a predicted ventricular pacing rate>20%
  • Patients with intraventricular septal diameter>8mm
  • Written informed consent

Exclusion Criteria:

  • Indication for CRT or ICD device
  • Patients with no subclavian approach, who are candidates for leadless devices
  • Presence of severe tricuspid regurgitation
  • Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Left Bundle Branch Pacing
Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing
Device: Left bundle branch pacing lead (Select Secure 3830 lead)
Implantation of a left bundle branch pacing lead via sheath
Active Comparator: Conventional Right Venticular Pacing
The ventricular lead will be implanted in the right ventricle in the conventional way
Device: Right ventricular active fixation lead
Active fixation lead (standard)

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
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure Time (min)
Time Frame: 1 Day of procedure
The total time required for the completion of the procedure
1 Day of procedure
Fluoroscopy Time (min)
Time Frame: 1 Day of procedure
The total time of fluoroscopy
1 Day of procedure
Dose Area Product (DAP) (cGy/cm2)
Time Frame: 1 Day of procedure
Total Radiation Dose as expressed with DAP
1 Day of procedure
Implant success
Time Frame: 1 Day of procedure
Successful implantation with pacing threshold<2 V
1 Day of procedure
Complications associated with pacemaker implantation
Time Frame: through study completion at 1 year post randomisation
General device related complications: pneumothorax, hemothorax, infection, tamponade, hematoma, lead reoperation Specific complications associated with the left bundle branch pacing procedure: intraventricular septum rupture, septal perforator branch injury with subsequent myocardial infarction or lead displacement
through study completion at 1 year post randomisation
B natriuretic peptide measurement (pg/ml)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Stroke volume index (SVi) (ml/m2)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the SVi will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Ejection Fraction (EF) (%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the EF will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Longitudinal Strain (GLS) (%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the GLS will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain (%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain Rate (1/s)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain Rate will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Aortic Time- Velocity Integral (TVI) (cm)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the aortic TVI will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Work Index (GWI) (mmHg%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Constructive Work (GCW) (mmHg%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Wasted Work (GWW) (mmHg%)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the mid septal wall
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the mid septal wall will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the basal lateral wall
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the basal lateral wall will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Peak Strain Dispersion (PSD) (msec)
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in capture threshold (V) in the ventricular lead
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and the potential changes in capture threshold in the ventricular lead will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in sense (mV) in the ventricular lead
Time Frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and potential changes in sense in the ventricular lead will be recorded
24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure

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.
University Hospital of Patras

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georgios Leventopoulos, MD, PhD, University Hospital of Patras

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.
July 13, 2021

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 20, 2022

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 20, 2022

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).
October 29, 2021

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.
November 19, 2021

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.
November 22, 2021

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.
October 27, 2023

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.
October 25, 2023

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.
October 1, 2023

More Information

Terms related to this study

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.
  • 251/10-05-21

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings