Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045143

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker DDD	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 Design

Study Type:

Observational

Anticipated Enrollment :

54 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Right ventricular apical versus septal pacing Echocardiographic study. [1year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Ehdaa Adel Mosallam, Resident doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT06045143

Other Study ID Numbers:

LV strain in pacemaker's

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 25, 2023