NCT06045143

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 13, 2023

Last Update Submit

September 22, 2023

Conditions

Pacemaker DDD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Apical pacing

Study LV strain with speckle Echo when lead of pacemaker on apical site

Device: Patients undergoing DDD pacemaker implantation

Septal pacing

Study LV strain with speckle Echo when lead of pacemaker on septal site

Device: Patients undergoing DDD pacemaker implantation

Interventions

Patients undergoing DDD pacemaker implantationDEVICE

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

Apical pacingSeptal pacing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share