Outcome of Transcatheter Closure of Patent Ductus Arterio... | NCT06634407

Studies
Outcome of Transcatheter Closure of Patent Ductus Arteriosus in Pediatric Cardiology Unit in 3 Years Duration

NCT06634407

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Oct 22, 2024Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Patent Ductus Arteriosus (PDA)

Interventions

transcatheter closure

Countries

Not provided

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2024Estimated

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Sep 15, 2025Estimated

First Submitted Date

Oct 8, 2024

First Submission Date that Met QC Criteria

Oct 8, 2024

First Posted Date

Oct 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

Oct 21, 2024

Last Update Posted Date

Oct 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Transcatheter Closure of Patent Ductus Arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PDA patients	Other		Procedure: transcatheter closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcatheter closure	Procedure	using transcatheter closure of PDA to detect outcome of patients with PDA	PDA patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
outcome of trancathter PDA closure	outcome of 90 patients with trancatheter PDA closure in pediatrics using post procedure catheter and echocardiography	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with Patent Ductus Arteriosus confirmed by echocardiography
aged from 6 months to 16 years underwent percutaneous transcatheter PDA closure at Pediatric Cardiology Unit.

Exclusion Criteria:

Children with PDA younger than 6 months or older than 16 years and that are not candidate for transcatheter closure .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bassem Eldaba Fares bassem fares	Contact	+201220851469		basam.13298661@med.aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004374	Ductus Arteriosus, Patent

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

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Browse Branches

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