Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)

Egyptian Biomedical Research Network

Status: Completed

Conditions: Hemodynamically Significant PDA

Treatments: Device: Transcatheter PDA closure

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06763978

36264PR897/10/24

Details and patient eligibility

About

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.

Enrollment: 357 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• any patient with hemodynamically significant PDA

Exclusion criteria

• patient with pulmonary hypertension and Eisenmenger syndrome

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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357 participants in 3 patient groups

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

Active Comparator group

Treatment:

Device: Transcatheter PDA closure

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

Active Comparator group

Treatment:

Device: Transcatheter PDA closure

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

Active Comparator group

Treatment:

Device: Transcatheter PDA closure