Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Last updated: January 8, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Defect

Treatment

Amplatzer Piccolo Occluder

Clinical Study ID

NCT04371081
ABT-CIP-10290
  • Ages > 3
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 topulmonary hypertension

  • Thrombus in the implant site, or sign of venous thrombus in a vessel in which theoccluder is inserted and delivered

  • Endocarditis, or infection that can cause bacteremia

  • Allergic or potentially allergic to nickel

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Amplatzer Piccolo Occluder
Phase:
Study Start date:
April 01, 2020
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Showa University Hospital

    Tokyo,
    Japan

    Site Not Available

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