The U.S. PDA Registry

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Le Bonheur Children's Hospital
Study ID
NCT04205877
Status
Not Yet Recruiting

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Conditions

  • Ductus Arteriosus, Patent

Eligibility Criteria

Sex
ALL
Age
3 Days - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter PDA Closure — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
Dec 2019
Primary completion
Jan 1, 2030
Completion
Dec 1, 2031

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: Registry Group
    All participants will have the same data collected at the same time points.

Primary Outcome Measure

Vascular Access Complications (Safety) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
LeBonheur Children's HospitalMemphisTennessee38103
Shyam K Sathanandam, MD
[email protected]
901-287-6380
Jorden Cunningham, BSN
[email protected]
901-287-7457

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By research site
LeBonheur Children's Hospital· Memphis, TN

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