Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    70
  • sponsor
    Abbott Medical Devices
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Updated on 16 February 2024
See if I qualify

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.

Details
Condition Congenital Heart Defect, Congenital Heart Disease, Patent ductus arteriosus, Congenital Heart Disease
Age 100years or below
Treatment Amplatzer Piccolo Occluder
Clinical Study IdentifierNCT04371081
SponsorAbbott Medical Devices
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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