The U.S. PDA Registry

Le Bonheur Children's Hospital

Status: Not yet enrolling

Conditions: Ductus Arteriosus, Patent

Treatments: Device: Transcatheter PDA Closure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04205877

The U.S. PDA Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 3 days to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of PDA.
2. Clinical indication for transcatheter PDA closure (discretion of the physician).
3. Weight <2 kg at the time of device implant.

Exclusion criteria

1. Weight <700 gm or greater than or equal to 2 kg at the time of device implant.
2. Age < 3 days at the time of device implant.
3. Pre-existing coarctation of the aorta.
4. Pre-existing left pulmonary artery stenosis.
5. Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
6. Intracardiac thrombus that interferes with device implant.
7. Active infection requiring treatment at the time of impant.

Trial design

5,000 participants in 1 patient group

Registry Group

Description:

All participants will have the same data collected at the same time points.

Treatment:

Device: Transcatheter PDA Closure