Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Completed

• Conditions: Echocardiography; PDA
• Interventions: Other: Echocardiography guide

• Registration Number: NCT05321849
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

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.

Study Timeline

• Study Start: 2019-03-12
• Primary Completion: 2020-06-23
• Study Completion: 2020-06-23
• Study First Submitted: 2022-03-22
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-11
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• PDA, age <= 18yo

Exclusion Criteria

• >= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No fluoroscopy (test)	Echocardiography guide	PDA closure in 30 patients with echocardiography guide, without fluoroscopy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complication	6, 24hours, and 48hours	if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade
Procedural time	6hours	Time total needed to complete procedure

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita Jakarta Indonesia; 🇮🇩 Jakarta, Indonesia