Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patent Ductus Arteriosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Amplatzer Piccolo Occluder

Amplatzer Piccolo Occluder device implant

Amplatzer Piccolo Occluder

Intervention Type DEVICE

Interventional placement of vascular occluder

Interventions

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Amplatzer Piccolo Occluder

Interventional placement of vascular occluder

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No