Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study

This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.

Study Overview

• Status: Not yet recruiting
• Conditions: Pacemaker DDD
• Intervention / Treatment: Device: Patients undergoing DDD pacemaker implantation

Detailed Description

Permanent cardiac pacing is the most efficient treatment for various conduction disorders, including high-degree atrioventricular block and symptomatic sick sinus syndrome. High-burden right ventricular (RV) pacing is often tolerated for decades without overt left ventricular (LV) failure in most patients. It has been shown, however, that prolonged RV pacing reduces LV function and ultimately causes heart failure. Left ventricular ejection fraction (LVEF) may decrease in specific individuals with pacemaker implants following pacing, which is called Pacing-induced cardiomyopathy (PICM). However, pacing-induced LV dysfunction (PIVD) at milder severity levels has also been documented.RV apical pacing, the classic site for pacemaker lead implantation, results in ventricular dys-synchrony and deterioration of left ventricular (LV) function and ejection fraction, like left bundle branch block. Recently, alternative sites are arising, such as right ventricular outflow tract (RVOT) and the septum. Studies show that deformation imaging by speckle tracking echocardiography following pacemaker implantation can predict the patients at higher risk for PCIM and PIVD at long-term follow-up. Deformation imaging, or strain imaging, provides unique Information on regional and global ventricular function. Global longitudinal strain is Known to be more precise than ejection Fraction. It is now used in patients with heart failure, ischemic heart disease, and Receiving chemotherapy to detect early Changes in cardiac function before changes in ejection fraction. Speckle tracking Echocardiography for strain measurement Depends on tracking of speckles throughout the Cardiac cycle in apical 4,3, and 2 chamber Views. The software allows the elaboration of myocardial deformation in 3 spatial directions: Longitudinal, radial, and circumferential. Predicting PICM and PIVD 6 months after pacemaker implantation is possible by measuring global longitudinal strain (GLS) baseline one and six months after implantation.

• Study Type: Observational
• Enrollment (Estimated): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Fifty-four patients with high degree AV block elicited for permanent pacemaker implantation were enrolled in this study

Description

Inclusion Criteria:

1. Any patients older than 18 years with conduction disturbances necessitating pacemaker implantation and
2. who had preserved LVEF (≥50%) were presented to Assuit University Heart Center.

Exclusion Criteria:

1. Patients with impaired systolic function (LVEF <50%).
2. Ischemic heart disease.
3. Significant valvular heart disease (moderate to severe).
4. Pregnancy.
5. Poor echogenic window.
6. Patient refusal.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apical pacing; Study LV strain with speckle Echo when lead of pacemaker on apical site	Device: Patients undergoing DDD pacemaker implantation; compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.
Septal pacing; Study LV strain with speckle Echo when lead of pacemaker on septal site	Device: Patients undergoing DDD pacemaker implantation; compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular apical versus septal pacing Echocardiographic study.	This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.	1year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LV strain in pacemaker's

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No