Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Study Overview
=================
Brief Summary
-----------------
Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience. Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Echocardiography-guided PDA closure is non-inferior to fluoroscopy-guided PDA closure, with similar procedural times. However, this method is operator-dependent and requires an experienced team for it to be performed successfully.

Detailed Description
-----------------
From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants for this prospective, single-centre, non-randomized clinical trial. They were divided equally into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy and the echocardiography group who underwent percutaneous PDA closures guided by transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. Ductal morphology was evaluated using multiplanar TTE and TEE imaging. After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. This study protocol conforms to the ethical guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the Research Ethics Committee of National Cardiovascular Center Harapan Kita No LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.

Official Title
-----------------
Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia

Conditions
-----------------
PDA, Echocardiography

Intervention / Treatment
-----------------
* Other: Echocardiography guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PDA, age <= 18yo Exclusion Criteria: >= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use Fluoroscopy (Control)<br>PDA closure in 30 patients with fluoroscopy guide | |
| No fluoroscopy (test)<br>PDA closure in 30 patients with echocardiography guide, without fluoroscopy | Other: Echocardiography guide<br>* Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours | PDA residual shunt post PDA closure | 6, 24 hours, and 48 hours | 
| Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours | If device dislodge during follow-up | 6, 24 hours, and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time | Time total needed to complete procedure | 6hours | 
| Complication | if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade | 6, 24hours, and 48hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patent Ductus Arteriosus (PDA), Transcatheter closure, Without fluoroscopy, echocardiography