What this study is
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.
What's being tested
- Transcatheter PDA Closure
Intervention · 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
- Official title
- The United States Patent Ductus Arteriosus Registry
- Sponsor
- Le Bonheur Children's Hospital
- Conditions
- Ductus Arteriosus, Patent
- Enrolling
- 5,000 people
- Starts
- 2020-01-01
- Est. completion
- 2031-12-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Days – 1 YearSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of PDA.
- Clinical indication for transcatheter PDA closure (discretion of the physician).
- Weight <2 kg at the time of device implant.
You can't join if
- Weight <700 gm or greater than or equal to 2 kg at the time of device implant.
- Age < 3 days at the time of device implant.
- Pre-existing coarctation of the aorta.
- Pre-existing left pulmonary artery stenosis.
- Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
- Intracardiac thrombus that interferes with device implant.
- Active infection requiring treatment at the time of impant.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openLeBonheur Children's Hospital
Memphis, Tennessee, United States
- Shyam K Sathanandam, MD · Contact901-287-6380ssathan@uthsc.edu
- Jorden Cunningham, BSN · Contact901-287-7457jorden.cunningham@lebonheur.org
Study team
Sponsor
Le Bonheur Children's Hospital
Study ID The U.S. PDA Registry
Principal investigator
Shyam Sathanandam, MD
National Principal Investigator
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.