Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Patent Ductus Arteriosus Clinical Trial

Official title:

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04371081
• Other study ID #: ABT-CIP-10290
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: Yuri Masui
• Phone: +81-3-3524-1792
• Email: yuri.masui[@]abbott.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Device:
• Amplatzer Piccolo Occluder
Interventional placement of vascular occluder

Locations

Country	Name	City	State
Japan	Showa University Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Japanese society of Congenital Interventional Cardiology

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of major complications through 180 days after an attempted Piccolo device implant		Through 180 days after an attempted Piccolo device implant
Primary	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