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Completed

NCT Number: NCT05321849

Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

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.

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Key information

Conditions

Echocardiography Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases PDA

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cardiovascular Center Harapan Kita Jakarta Indonesia

Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PDA, age <= 18yo

Exclusion criteria

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

Treatment and study plan

Echocardiography guide

Other

Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures

Primary outcomes

  1. Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours

    Time frame: 6, 24 hours, and 48 hours

    PDA residual shunt post PDA closure

  2. Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours

    Time frame: 6, 24 hours, and 48 hours

    If device dislodge during follow-up

Secondary outcomes

  1. Procedural time

    Time frame: 6hours

    Time total needed to complete procedure

  2. Complication

    Time frame: 6, 24hours, and 48hours

    if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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