Last reviewed · How we verify

NCT05321849

Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Completed Last updated 11 April 2022
What this trial tests

trial testing Echocardiography guide in Echocardiography in 60 participants. Completed in 23 June 2020.

Timeline
12 March 2019
Primary endpoint
23 June 2020
23 June 2020

Quick facts

Lead sponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment60
Start date12 March 2019
Primary completion23 June 2020
Estimated completion23 June 2020
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Who can join

Adults 0 to 18, any sex, with Echocardiography or PDA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia.
    Siagian SN, Prakoso R, Putra BE, Kurniawati Y, et al · · 2022 · cited 11× · PMID 35677684 · DOI 10.3389/fcvm.2022.885140

Verify or expand the search:

Other recruiting trials for Echocardiography

Currently open trials in the same condition.

Other National Cardiovascular Center Harapan Kita Hospital Indonesia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05321849.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing