NCT04205877

The U.S. PDA Registry

The United States Patent Ductus Arteriosus Registry

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Le Bonheur Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Days – 1 Year
• Healthy volunteers: —

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.

Detailed description

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.

Conditions

• Ductus Arteriosus, Patent

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2030-01-01
• Completion: 2031-12-01
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study