The U.S. PDA Registry

Official title

The United States Patent Ductus Arteriosus Registry

Overview

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.

Interventions

• 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.

Primary outcome measures

• Vascular Access Complications (Safety) [Time frame: 6 months]
• Valvular Injury (Safety) [Time frame: 6 months]
• Device Embolization (Safety) [Time frame: 6 months]
• Pulmonary or Aortic Vessel Stenosis (Safety) [Time frame: 6 months]
• Rate of Effective PDA Closure (Effectiveness) [Time frame: 6 months]

Secondary outcome measures (2)

• Significant obstruction of the left pulmonary artery [Time frame: 6 months]
• Significant obstruction of the aorta [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Case-only

Study locations

United States · 1 center

• LeBonheur Children's Hospital — Memphis

Publications

• Tashiro J, Perez EA, Sola JE. Reduced Hospital Mortality With Surgical Ligation of Patent Ductus Arteriosus in Premature, Extremely Low Birth Weight Infants: A Propensity Score-matched Outcome Study. Ann Surg. 2016 Mar;263(3):608-14. doi: 10.1097/SLA.0000000000001228. PMID 25822689
• Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025. PMID 22414886
• Mahoney LT, Coryell KG, Lauer RM. The newborn transitional circulation: a two-dimensional Doppler echocardiographic study. J Am Coll Cardiol. 1985 Sep;6(3):623-9. doi: 10.1016/s0735-1097(85)80123-6. PMID 4031274
• Philip R, Waller BR 3rd, Agrawal V, Wright D, Arevalo A, Zurakowski D, Sathanandam S. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device. Catheter Cardiovasc Interv. 2016 Feb 1;87(2):310-7. doi: 10.1002/ccd.26287. Epub 2015 Nov 3. PMID 26525611
• Krichenko A, Benson LN, Burrows P, Moes CA, McLaughlin P, Freedom RM. Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol. 1989 Apr 1;63(12):877-80. doi: 10.1016/0002-9149(89)90064-7. No abstract available. PMID 2929450
• Pass RH. Amplatzer Duct Occluder device: a new technology for the closure of the moderate-to-large-sized patent ductus arteriosus. Expert Rev Med Devices. 2006 May;3(3):291-6. doi: 10.1586/17434440.3.3.291. PMID 16681450
• Moore JW, Levi DS, Moore SD, Schneider DJ, Berdjis F. Interventional treatment of patent ductus arteriosus in 2004. Catheter Cardiovasc Interv. 2005 Jan;64(1):91-101. doi: 10.1002/ccd.20243. PMID 15619281
• Perlo f, Joseph K.The Clinical Recognition of Congenital Heart Disease. Philadelphia: Saunders. Print.

Identifiers

NCT: NCT04205877 · The U.S. PDA Registry

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗