Ductus Arteriosus, Patent Clinical Trial
Official title:
The United States Patent Ductus Arteriosus 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 USA.
Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children < 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children < 2kg performed in the USA.This study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. This will allow us to understand the real world experience (efficacy and safety) of using the Amplatzer Piccolo Occluder and other devices in an extremely vulnerable, yet highly underserved population. The study will allow for standardization of this procedure throughout the country for the small children (<2 kg) with a PDA. This is a multi-center, single arm, observational data collection study. This will be a large population study to help analyze outcomes in subjects <2 kg. The trial has two primary endpoints for safety and effectiveness without formal hypothesis. The safety and effectiveness results will be compared with data reported in the ADO II AS IDE and Continued Access Protocol studies. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03604796 -
Alternative Paracetamol Treatments for the Neonate With a hsPDA
|
Phase 2/Phase 3 | |
| Completed |
NCT00000494 -
Management of Patent Ductus in Premature Infants
|
Phase 3 | |
| Completed |
NCT01251939 -
Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious
|
N/A | |
| Completed |
NCT01031316 -
Patent Ductus Arteriosus (PDA) Screening Trial
|
N/A | |
| Completed |
NCT00828334 -
NIT-OCCLUD PDA Phase II Sentinel Trial
|
N/A | |
| Completed |
NCT00009646 -
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
|
Phase 3 | |
| Withdrawn |
NCT00470743 -
Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies
|
Phase 4 | |
| Completed |
NCT00725647 -
Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
|
N/A | |
| Terminated |
NCT00239512 -
New Management Strategy of PDA for VLBW Preterm Infants
|
N/A | |
| Recruiting |
NCT04508036 -
Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels
|
||
| Completed |
NCT01243996 -
High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant
|
Phase 2/Phase 3 | |
| Completed |
NCT00005190 -
Reproduction and Survival After Cardiac Defect Repair
|
N/A | |
| Recruiting |
NCT05547165 -
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
|
N/A | |
| Completed |
NCT02422966 -
Paracetamol in Patent Ductus Arteriosus
|
Phase 2 | |
| Completed |
NCT02803671 -
Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data
|
N/A | |
| Completed |
NCT00799123 -
Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants
|
N/A | |
| Completed |
NCT00528736 -
Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks
|
N/A | |
| Completed |
NCT02002741 -
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
|
Phase 2/Phase 3 |