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| Name | Class |
|---|---|
| Japanese society of Congenital Interventional Cardiology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amplatzer Piccolo Occluder | Amplatzer Piccolo Occluder device implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amplatzer Piccolo Occluder | Device | Interventional placement of vascular occluder |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of major complications through 180 days after an attempted Piccolo device implant | 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 | At the 6-month follow-up |
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Inclusion Criteria:
The device is used to percutaneously close the PDA of a patient who meets all of the following:
Exclusion Criteria:
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All patients with patent ductus arteriosus (PDA) in whom an Amplatzerâ„¢ Piccolo Occluder (Piccolo) implant was attempted will be included in this registry.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Showa University Hospital | Tokyo | Japan |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |