Active — Not RecruitingNot Applicable

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Japan70 participantsStarted 2020-04-01

Plain-language 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.

Who can participate

Age range3 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: At the 6-month follow-up

Trial details

NCT IDNCT04371081

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-10

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials