Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia (Other)

Overall Status

Completed

CT.gov ID

NCT05321849

Collaborator

(none)

Enrollment

Location

15.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Echocardiography PDA	Other: Echocardiography guide

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 12, 2019

Actual Primary Completion Date :

Jun 23, 2020

Actual Study Completion Date :

Jun 23, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Use Fluoroscopy (Control)

PDA closure in 30 patients with fluoroscopy guide

No fluoroscopy (test)

PDA closure in 30 patients with echocardiography guide, without fluoroscopy

Other: Echocardiography guide

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

PDA, age <= 18yo

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cardiovascular Center Harapan Kita Jakarta Indonesia	Jakarta		Indonesia	11420

Sponsors and Collaborators

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

Principal Investigator: Sisca N Siagian, MD, National CCHK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sisca Natalia Siagian, Principal Investigator, National Cardiovascular Center Harapan Kita Hospital Indonesia

ClinicalTrials.gov Identifier:

NCT05321849

Other Study ID Numbers:

LB.02.01/VII/475/KEP076/

First Posted:

Apr 11, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sisca Natalia Siagian, Principal Investigator, National Cardiovascular Center Harapan Kita Hospital Indonesia

Patent Ductus Arteriosus (PDA)

Transcatheter closure

Without fluoroscopy

echocardiography

Additional relevant MeSH terms:

Ductus Arteriosus, Patent

Study Results

No Results Posted as of Apr 11, 2022