Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

NCT05321849 | Completed DMC

• 1 other identifier: LB.02.01/VII/475/KEP076/
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography; PDA

Keywords

Patent Ductus Arteriosus (PDA); Transcatheter closure; Without fluoroscopy; echocardiography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Procedural time

  6hours

• Complication

  6, 24hours, and 48hours

Study Arms (2)

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

Interventions

Echocardiography guide OTHER

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

No fluoroscopy (test)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria for this study are children under 18 years old with PDA who were planned for PDA closure. The exclusion criteria include the coexistence of other associated congenital heart disease requiring surgical intervention and PDA patients with irreversible high pulmonary vascular resistance (PVR) unreactive with the oxygen test.

You may qualify if:

• PDA, age \<= 18yo

You may not qualify if:

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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita Jakarta Indonesia

Jakarta, 11420, Indonesia

Location

Related Publications (1)

• Siagian SN, Prakoso R, Putra BE, Kurniawati Y, Lelya O, Sembiring AA, Atmosudigdo IS, Roebiono PS, Rahajoe AU, Harimurti GM, Mendel B, Christianto C, Setiawan M, Lilyasari O. Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia. Front Cardiovasc Med. 2022 May 23;9:885140. doi: 10.3389/fcvm.2022.885140. eCollection 2022.

  PMID: 35677684 DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sisca N Siagian, MD

  National CCHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 11, 2022
• Study Start: March 12, 2019
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)