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Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

NCT04371081 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-10-03

No results posted yet for this 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.

Conditions

  • Patent Ductus Arteriosus

Interventions

DEVICE

Amplatzer Piccolo Occluder

Interventional placement of vascular occluder

Sponsors & Collaborators

  • Japanese society of Congenital Interventional Cardiology

    collaborator UNKNOWN

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2025-09-10
Completion
2027-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04371081 on ClinicalTrials.gov