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NCT04205877 · ClinicalTrials.gov registry record
The U.S. PDA Registry
A clinical trial, sponsored by Le Bonheur Children's Hospital.
- Not yet
- Registry status
- 5,000
- Enrollment target
NCT04205877: Clinical Trial study, sponsored by Le Bonheur Children's Hospital.
NCT04205877 is a clinical trial that has not yet begun recruiting, run by Le Bonheur Children's Hospital. The registered enrollment target is 5,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04205877 has not yet begun recruiting, sponsored by Le Bonheur Children's Hospital.
- NOT YET RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
Study 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.
Primary Outcome
Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (\>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.
Interventions
- DEVICE Transcatheter PDA Closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2031-12-01 |
What is known before NCT04205877 opens enrollment
NCT04205877 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Transcatheter PDA Closure is the first listed.
NCT04205877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04205877 about?
NCT04205877 is a clinical study titled "The U.S. PDA Registry". 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...
What is the current status of trial NCT04205877?
This trial is currently not yet recruiting. The enrollment target is 5,000 participants. The study started on 2020-01-01. Estimated completion is 2031-12-01.
What interventions are being tested in trial NCT04205877?
The interventions under investigation include: Transcatheter PDA Closure (DEVICE).
Who is sponsoring clinical trial NCT04205877?
This trial is sponsored by Le Bonheur Children's Hospital, which has 14 total clinical trials registered on ClinicalTrials.gov.
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