Effect of Site of Right Ventricular (RV) Pacing on RV Function, Left Ventricular (LV) Dyssynchrony and Contraction Efficiency

October 9, 2024 updated by: Mustafa Mohamed Ahmed Mohamed Ali, South Valley University
To evaluate RV systolic function and LV mechanical dyssynchrony and function in different lead position in the RV during permanent pacemaker implantation by using speckle tracking echocardiography (STE) and 3D volumetric ejection fraction

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

Permanent pacing with right ventricular stimulation is the standard method used in patients with bradyarrhythmia, and recommended by current international guidelines because it is associated with improved clinical outcomes. The extent of right ventricular pacing (RVP) varies between patients and many individuals tolerate a high proportion of RVP without complications. However, chronic RVP may cause electrical and mechanical dyssynchrony that may lead to impaired left ventricular ejection fraction (LVEF). Dyssynchronous ventricles require more oxygen to generate the same amount of mechanical work and the consequence is a decline in the efficieny of myocardial contraction. RV septal pacing (RVS) is thought to allow more physiological LV depolarisation, than RV apical pacing (RVA) with preservation of LV function. However, there are conflicting data on its benefits, and the recently completed Protect-Pace (The protection of LV function during RV pacing) study showed both RVA and non-RVA pacing to have a small adverse effect on EF in patients with preserved LV function, but no difference between the methods. The effect of RV pacing on RV function has not been evaluated systematically, with most studies focusing on tricuspid regurgitation (TR) as the outcome of interest. Echocardiographic assessment of LV dyssynchrony has been extensively used because it is noninvasive, widely available, and has no known risk or side effect. Speckle tracking echocardiography is a novel echocardiographic technique without the angle dependence of an ultrasound beam and is able to measure regional deformation in any direction in the LV and RV, that can detect subtle myocardial dysfunction because it is more sensitive compared with conventional parameters, Furthermore, strain imaging can display the timing and extent of myocardial thickening and stretching so that it is well suited to estimate the amount of inefficient dyssynchronous contraction. Global Longitudinal Strain (GLS) and LV mechanical function and dyssynchrony assessment by speckle-tracking echocardiography (STE) enables us to detect subclinical LV dysfunction. And also a very attractive clinical tool for the assessment of right ventricular (RV) systolic performance, providing incremental diagnostic and prognostic information over the traditional indices of RV function, Among various imaging modalities, echocardiography is currently the method of choice for clinical assessment of RV longitudinal strain (RVLS). The methodology of speckle-tracking echocardiography to obtain RVLS has been recently standardized and demonstrated to be feasible, accurate, and robust for clinical use. Inter-technique and inter-vendor comparability and reliability of RVLS are improving. RVLS is advantageous because it is more sensitive to subtle changes in myocardial function than conventional parameters used to assess RV function (i.e. tricuspid annular plane systolic excursion, tissue Doppler systolic velocity, fractional area change, or RV ejection fraction) representing a sensitive tool for the long-term follow-up of patients.

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.
52

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 Locations

  • Egypt
      • Qena Governorate, Egypt, 83523
        • South Valley 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients with symptomatic bradycardia indicated for permanent pacemaker implantation according to recent European guidelines.

Exclusion Criteria:

  • Patients with reduced RV function.
  • Patients with reduced LV systolic function.
  • Significant valvular lesions.
  • Congenital heart disease that might affect RV and/or LV function.
  • Patients undergoing CRT or Implantable Cardioverter-Defibrillator (ICD).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Active Comparator: RV Apical pacing
Patient with the pacemaker RV lead located at the RV apex
Device: Pacemaker and defibrillator
Permenant pacemaker implantation with lead fixed to the RV Septal location
Other Names:
  • Pacemaker lead location to the RV septum
Device: Pacemaker and defibrillator
Description: Permenant pacemaker implantation with lead fixed to the RV Apical location
Other Names:
  • Pacemaker lead location to the RV Apex
Active Comparator: RV Septal pacing
Patient with the pacemaker RV lead located at the RV septum.
Device: Pacemaker and defibrillator
Permenant pacemaker implantation with lead fixed to the RV Septal location
Other Names:
  • Pacemaker lead location to the RV septum
Device: Pacemaker and defibrillator
Description: Permenant pacemaker implantation with lead fixed to the RV Apical location
Other Names:
  • Pacemaker lead location to the RV Apex

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
To detect a 3% difference in Longitudinal Strain (GLS) between groups.
Time Frame: 6 months

To detect a 3% difference in Longitudinal Strain (GLS) between group A (right ventricular apex) and the group B (right ventricular septum).

A standard deviation of 4% was used for the sample size calculation based on previous studies
6 months

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.
South Valley University

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.
  • Study Director: Minia University, Minia University, faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
August 15, 2022

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.
March 15, 2024

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.
August 15, 2024

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).
September 11, 2024

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.
October 9, 2024

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.
October 15, 2024

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 15, 2024

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 9, 2024

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, 2024

More Information

Terms related to this study

Keywords

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.
  • RV Pacemaker lead location

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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