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Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

NCT05321849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-04-11

No results posted yet for this study

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

Interventions

OTHER

Echocardiography guide

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

Sponsors & Collaborators

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    lead OTHER

Principal Investigators

  • Sisca N Siagian, MD · National CCHK

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2020-06-23
Completion
2020-06-23

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321849 on ClinicalTrials.gov