Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

NCT ID: NCT05321849

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2020-06-23

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.

Conditions

Echocardiography; PDA

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Use Fluoroscopy (Control)

PDA closure in 30 patients with fluoroscopy guide

No interventions assigned to this group

No fluoroscopy (test)

PDA closure in 30 patients with echocardiography guide, without fluoroscopy

Echocardiography guide

Intervention Type: OTHER

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

Interventions

Echocardiography guide

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• PDA, age <= 18yo

Exclusion Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Sisca Natalia Siagian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sisca N Siagian, MD

Role: PRINCIPAL_INVESTIGATOR

National CCHK

Locations

National Cardiovascular Center Harapan Kita Jakarta Indonesia

Jakarta, , Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 35677684 (View on PubMed)

Other Identifiers

LB.02.01/VII/475/KEP076/

Identifier Type: -

Identifier Source: org_study_id