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The U.S. PDA Registry
Sponsor: Le Bonheur Children's Hospital
Summary
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.
Official title: The United States Patent Ductus Arteriosus Registry
Key Details
Gender
All
Age Range
3 Days - 1 Year
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2020-01-01
Completion Date
2031-12-01
Last Updated
2019-12-20
Healthy Volunteers
Not specified
Conditions
Interventions
Transcatheter PDA Closure
Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
Locations (1)
LeBonheur Children's Hospital
Memphis, Tennessee, United States