Status:
ACTIVE_NOT_RECRUITING
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Japanese society of Congenital Interventional Cardiology
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
3+ years
Brief 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 me...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04371081
Start Date
April 1 2020
End Date
July 31 2027
Last Update
October 3 2025
Active Locations (1)
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1
Showa University Hospital
Tokyo, Japan