Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Active, not recruiting

• Conditions: Patent Ductus Arteriosus
• Interventions: Device: Amplatzer Piccolo Occluder

• Registration Number: NCT04371081
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The device is used to percutaneously close the PDA of a patient who meets all of the following:

• PDA ≤4 mm in diameter
• PDA ≥3 mm in length
• Weight ≥700 g

Exclusion Criteria

• Age <3 days
• Coarctation of the aorta
• Left pulmonary artery stenosis
• Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
• Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered
• Endocarditis, or infection that can cause bacteremia
• Allergic or potentially allergic to nickel

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amplatzer Piccolo Occluder	Amplatzer Piccolo Occluder	Amplatzer Piccolo Occluder device implant

Primary Outcome Measures

Name	Time	Method
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
The rate of major complications through 180 days after an attempted Piccolo device implant	Through 180 days after an attempted Piccolo device implant

Trial Locations

Locations (1)

Showa University Hospital; 🇯🇵 Tokyo, Japan