Clinical trial NCT04205877: The U.S. PDA Registry
Official title: The United States Patent Ductus Arteriosus Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ductus Arteriosus, Patent
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2019-12-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients with diagnosis of PDA with clinical indication for transcatheter PDA closure, and weigh less than 2 kg at the time of device implant.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vascular Access Complications (Safety)
timeFrame: 6 months
measure: Valvular Injury (Safety)
timeFrame: 6 months
measure: Device Embolization (Safety)
timeFrame: 6 months
measure: Pulmonary or Aortic Vessel Stenosis (Safety)
timeFrame: 6 months
measure: Rate of Effective PDA Closure (Effectiveness)
timeFrame: 6 months
Secondary outcomes:
measure: Significant obstruction of the left pulmonary artery
timeFrame: 6 months
measure: Significant obstruction of the aorta
timeFrame: 6 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: National Principal Investigator
name: Shyam Sathanandam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Perlo f, Joseph K.The Clinical Recognition of Congenital Heart Disease. Philadelphia: Saunders. Print.
citation: Gross RE, Hubbard JP. Landmark article Feb 25, 1939: Surgical ligation of a patent ductus arteriosus. Report of first successful case. By Robert E. Gross and John P. Hubbard. JAMA. 1984 Mar 2;251(9):1201-2. doi: 10.1001/jama.251.9.1201. No abstract available.
citation: Kabra NS, Schmidt B, Roberts RS, Doyle LW, Papile L, Fanaroff A; Trial of Indomethacin Prophylaxis in Preterms Investigators. Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth weight infants: results from the Trial of Indomethacin Prophylaxis in Preterms. J Pediatr. 2007 Mar;150(3):229-34, 234.e1. doi: 10.1016/j.jpeds.2006.11.039.
citation: Chorne N, Leonard C, Piecuch R, Clyman RI. Patent ductus arteriosus and its treatment as risk factors for neonatal and neurodevelopmental morbidity. Pediatrics. 2007 Jun;119(6):1165-74. doi: 10.1542/peds.2006-3124.
citation: Teixeira LS, Shivananda SP, Stephens D, Van Arsdell G, McNamara PJ. Postoperative cardiorespiratory instability following ligation of the preterm ductus arteriosus is related to early need for intervention. J Perinatol. 2008 Dec;28(12):803-10. doi: 10.1038/jp.2008.101. Epub 2008 Jul 10.
citation: Porstmann W, Wierny L, Warnke H, Gerstberger G, Romaniuk PA. Catheter closure of patent ductus arteriosus. 62 cases treated without thoracotomy. Radiol Clin North Am. 1971 Aug;9(2):203-18. No abstract available.
citation: Weisz DE, McNamara PJ. Patent ductus arteriosus ligation and adverse outcomes: causality or bias? J Clin Neonatol. 2014 Apr;3(2):67-75. doi: 10.4103/2249-4847.134670.
citation: Gruenstein DH, Ebeid M, Radtke W, Moore P, Holzer R, Justino H. Transcatheter closure of patent ductus arteriosus using the AMPLATZER duct occluder II (ADO II). Catheter Cardiovasc Interv. 2017 May;89(6):1118-1128. doi: 10.1002/ccd.26968. Epub 2017 Mar 4.
citation: Kenny D, Morgan GJ, Bentham JR, Wilson N, Martin R, Tometzki A, Oslizlok P, Walsh KP. Early clinical experience with a modified Amplatzer ductal occluder for transcatheter arterial duct occlusion in infants and small children. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):534-40. doi: 10.1002/ccd.24522. Epub 2013 Jun 29.
citation: Sungur M, Karakurt C, Ozbarlas N, Baspinar O. Closure of patent ductus arteriosus in children, small infants, and premature babies with Amplatzer duct occluder II additional sizes: multicenter study. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):245-52. doi: 10.1002/ccd.24905. Epub 2013 Apr 8.
citation: Bruckheimer E, Godfrey M, Dagan T, Levinzon M, Amir G, Birk E. The Amplatzer Duct Occluder II Additional Sizes device for transcatheter PDA closure: initial experience. Catheter Cardiovasc Interv. 2014 Jun 1;83(7):1097-101. doi: 10.1002/ccd.25445. Epub 2014 Mar 4.
citation: Baspinar O, Sahin DA, Sulu A, Irdem A, Gokaslan G, Sivasli E, Kilinc M. Transcatheter closure of patent ductus arteriosus in under 6 kg and premature infants. J Interv Cardiol. 2015 Apr;28(2):180-9. doi: 10.1111/joic.12196. Epub 2015 Apr 2.