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NCT04371081
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Conditions: Patent Ductus Arteriosus
Sex: All
Ages: 3 Days – N/A
Healthy volunteers: No
Enrollment: 70
Sponsor: Abbott Medical Devices
Location: Showa University Hospital Tokyo
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 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 \
Source: ClinicalTrials.gov (NCT04371081). StuddyBuddy aggregates publicly available trial information.
