Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

NCT04371081 · tracked via the Priya Life Science Japan tracker

Sponsor

Abbott Medical Devices

Phase

Observational

Started

2020-04-01

Last updated

2025-10-03

Condition(s) studied

Patent Ductus Arteriosus

Investigational drug(s) / intervention(s)

Amplatzer Piccolo Occluder

Amplatzer Piccolo Occluder: Interventional placement of vascular occluder

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

Sex

ALL

Min age

3 Days

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The rate of major complications through 180 days after an attempted Piccolo device implant — Through 180 days after an attempted Piccolo device implant
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

Trial sites (1)

Facility	City	Region	Status
Showa University Hospital	Tokyo	Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04371081 on ClinicalTrials.gov ↗ ← All trials in Japan