Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Echocardiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321849
• Other study ID #: LB.02.01/VII/475/KEP076/
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: April 2022
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• PDA, age <= 18yo

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Echocardiography
• PDA

Intervention

Other:
• Echocardiography guide
Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita Jakarta Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Procedural time	Time total needed to complete procedure	6hours
Secondary	Complication	if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade	6, 24hours, and 48hours