NCT06763978

Brief Summary

We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size \& left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring both venous and arterial access for transcatheter PDA closure regarding the outcome \& complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

4.1 years

First QC Date

January 3, 2025

Last Update Submit

January 3, 2025

Conditions

Hemodynamically Significant PDA

Outcome Measures

Primary Outcomes (1)

  • procedural and fluoroscopy time

    during the procedure

Study Arms (3)

152 patients who underwent ordinary transcatheter closure technique using both arterial and venous a

ACTIVE COMPARATOR
Device: Transcatheter PDA closure

113 patients who underwent transcatheter closure using exclusive venous access only.

ACTIVE COMPARATOR
Device: Transcatheter PDA closure

included 92 patients who underwent transcatheter closure using exclusive arterial access only.

ACTIVE COMPARATOR
Device: Transcatheter PDA closure

Interventions

Transcatheter PDA closureDEVICE

Transcatheter PDA closure

113 patients who underwent transcatheter closure using exclusive venous access only.152 patients who underwent ordinary transcatheter closure technique using both arterial and venous aincluded 92 patients who underwent transcatheter closure using exclusive arterial access only.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any patient with hemodynamically significant PDA

You may not qualify if:

  • patient with pulmonary hypertension and Eisenmenger syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, 82005, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 8, 2025

Study Start

January 1, 2020

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)