An observational study in Patent Ductus Arteriosus, sponsored by Abbott Medical Devices. Active, not recruiting at 1 site in Japan. Open to participants aged 3 Days and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Abbott Medical Devices · Observational
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.
The Surveillance will be conducted per the standards required by the Ministry of Health, Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960, hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised PAL.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 52 observational studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with patent ductus arteriosus (PDA) in whom an Amplatzer™ Piccolo Occluder (Piccolo) implant was attempted will be included in this registry.
The device is used to percutaneously close the PDA of a patient who meets all of the following:
Exclusion Criteria:
Amplatzer Piccolo Occluder device implant
Device: Amplatzer Piccolo Occluder
Interventional placement of vascular occluder
The rate of major complications through 180 days after an attempted Piccolo device implant
Time frame: Through 180 days after an attempted Piccolo device implant
The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography
Time frame: At the 6-month follow-up
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices