NCT06492473

Brief Summary

ventricular septal defect(VSD) are one of the most common significant CHD and account for up to 40% of all cardiac abnormalities.VSD is commonly isolated defect as well as intrinsic component of several complex cardiac malformations including tetrology of fallot ,double- outlet right ventricle(RV),transposition of great vessles,aortic coartication or interruption ,and truncus arteriosus

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

June 24, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 1, 2024

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • size of VSD

    size of VSD in mm according echocardiology

    12 months

Interventions

ECHODEVICE

type and size of ventricular septal defect

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies

You may qualify if:

  • all children from date of birth to age of 16 years old including both genders diagnosed to have isolated VSD or apart from another cardiac anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Saxena A, Mehta A, Sharma M, Salhan S, Kalaivani M, Ramakrishnan S, Juneja R. Birth prevalence of congenital heart disease: A cross-sectional observational study from North India. Ann Pediatr Cardiol. 2016 Sep-Dec;9(3):205-9. doi: 10.4103/0974-2069.189122.

    PMID: 27625516BACKGROUND
  • Soto B, Becker AE, Moulaert AJ, Lie JT, Anderson RH. Classification of ventricular septal defects. Br Heart J. 1980 Mar;43(3):332-43. doi: 10.1136/hrt.43.3.332.

    PMID: 7437181BACKGROUND
  • Soto B, Ceballos R, Kirklin JW. Ventricular septal defects: a surgical viewpoint. J Am Coll Cardiol. 1989 Nov 1;14(5):1291-7. doi: 10.1016/0735-1097(89)90430-0.

    PMID: 2808985BACKGROUND
  • Kirklin JK, Castaneda AR, Keane JF, Fellows KE, Norwood WI. Surgical management of multiple ventricular septal defects. J Thorac Cardiovasc Surg. 1980 Oct;80(4):485-93.

    PMID: 7421283BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

amany S Thabit, Resident

CONTACT

mohamed A mohamed, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of pediatric and neonatology department, Sohag University Hospitals

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

June 24, 2024

Primary Completion

June 24, 2025

Study Completion

June 24, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations