Clinical trial NCT05321849: Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure
Official title: Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Echocardiography
PDA
Keywords: Patent Ductus Arteriosus (PDA)
Transcatheter closure
Without fluoroscopy
echocardiography
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Inclusion Criteria:

* PDA, age \<= 18yo

Exclusion Criteria:

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

Primary outcomes:
measure: Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours
timeFrame: 6, 24 hours, and 48 hours
measure: Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours
timeFrame: 6, 24 hours, and 48 hours
Secondary outcomes:
measure: Procedural time
timeFrame: 6hours
measure: Complication
timeFrame: 6, 24hours, and 48hours
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita Jakarta Indonesia
Study officials:
affiliation: National CCHK
name: Sisca N Siagian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.