The U.S. PDA Registry

NCT04205877 | Not Yet Recruiting FDA Device

• 1 other identifier: The U.S. PDA Registry
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus, Patent

Outcome Measures

Primary Outcomes (5)

• Vascular Access Complications (Safety)

  Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (\>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.

  6 months

• Valvular Injury (Safety)

  Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.

  6 months

• Device Embolization (Safety)

  Device embolization includes malposition of the device either during or after the procedure or delayed (\>24 hours). The outcome of device embolization ranges from observation, transcatheter retrieval at time of procedure or at a separate time, surgical retrieval, other end organ damage, to mortality.

  6 months

• Pulmonary or Aortic Vessel Stenosis (Safety)

  Adjacent vessel stenosis includes a narrowing of the aorta or the left pulmonary artery directly as a consequence of device implantation for PDA closure. Vessel stenosis could happen either during or after the procedure or delayed (\>24 hours). The outcome of vessel stenosis ranges from no intervention needed to repeated transcatheter and surgical therapies.

  6 months

• Rate of Effective PDA Closure (Effectiveness)

  The effectiveness endpoint is the rate of effective closure of the PDA using a transcatheter device within six months post procedure. If more than one attempt is required, or multiple devices are required during the same procedure, it is still considered effective if there is Grade 0 or Grade 1 shunt, as defined below, at follow-up by transthoracic echocardiography or if a second procedure is not required following the initial attempt. If there is device embolization, adjacent vessel stenosis that required retrieval of the device and replacement during the same procedure with less than Grade 1 shunt during follow-up, it is still considered effective. Conversely, if an AE is noted after the procedure that requires a second procedure for treatment that results in greater than Grade 1 shunt, then the procedure is considered not effective, even if the initial attempt was effective. See protocol for PDA shunt definitions.

  6 months

Secondary Outcomes (2)

• Significant obstruction of the left pulmonary artery

  6 months

• Significant obstruction of the aorta

  6 months

Study Arms (1)

Registry Group

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

Device: Transcatheter PDA Closure

Interventions

Transcatheter PDA Closure 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.

Registry Group

Eligibility Criteria

• Age: 3 Days - 1 Year
• Sex: all
• Age Groups: Child (0-17)
• 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.

You 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 may not qualify 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.

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead
• Abbott: collaborator

Study Sites (1)

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (19)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Perlo f, Joseph K.The Clinical Recognition of Congenital Heart Disease. Philadelphia: Saunders. Print.

  RESULT

• 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.

  PMID: 6363741 RESULT

• 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.

  PMID: 17307535 RESULT

• 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.

  PMID: 17545385 RESULT

• 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.

  PMID: 18615091 RESULT

• 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.

  PMID: 4938290 RESULT

• 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.

  PMID: 25024972 RESULT

• 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.

  PMID: 28258658 RESULT

• 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.

  PMID: 22718329 RESULT

• 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.

  PMID: 23460349 RESULT

• 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.

  PMID: 24532416 RESULT

• 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.

  PMID: 25832591 RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shyam Sathanandam, MD

  National Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shyam K Sathanandam, MD

CONTACT

901-287-6380; ssathan@uthsc.edu

Jorden Cunningham, BSN

CONTACT

901-287-7457; jorden.cunningham@lebonheur.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics, University of Tennessee. Director of Cath Lab, Le Bonheur Children's Hospital.

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available when it is collected and added to the national database. It will be available for 12 years.
• Access Criteria: Investigators will submit proposal to request data to the Proposal Review Committee. If approved, de-identified data will be shared.

Locations

US (1)