Clinical Evaluation Of Ventricular Septal Defect (VSD) In... | NCT06492473

Studies
Clinical Evaluation Of Ventricular Septal Defect (VSD) In Children at Sohag Univesity Hospital

NCT06492473

Sponsor

Sohag University

Status

Recruiting

Last Update Posted

Jul 9, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Ventricular Septal Defect

Interventions

ECHO

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2024Actual

Primary Completion Date

Jun 24, 2025Estimated

Completion Date

Jun 24, 2025Estimated

First Submitted Date

Jul 1, 2024

First Submission Date that Met QC Criteria

Jul 8, 2024

First Posted Date

Jul 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2024

Last Update Posted Date

Jul 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amany Sabry Thabet, Resident of pediatric and neonatology department, Sohag University Hospitals, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
ECHO	Device	type and size of ventricular septal defect

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
size of VSD	size of VSD in mm according echocardiology	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

16 Years

Standard Ages

Child

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
amany S Thabit, Resident	Contact	01200074781		amany.saber@med.sohag.edu.eg
mohamed A mohamed, Professor	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University hospitals	Recruiting	Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27625516	Background	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.
7437181	Background	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.

Type	Date	Date Unknown
Release	Jan 13, 2026
Reset	Jan 28, 2026

ID	Term
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases