The U.S. PDA Registry

Ductus Arteriosus, Patent Clinical Trial

Official title:

The United States Patent Ductus Arteriosus Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04205877
• Other study ID #: The U.S. PDA Registry
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2031

Study information

• Verified date: December 2019
• Source: Le Bonheur Children's Hospital
• Contact: Shyam K Sathanandam, MD
• Phone: 901-287-6380
• Email: ssathan[@]uthsc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 1, 2031
• Est. primary completion date: January 1, 2030
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent

Intervention

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.

Locations

Country	Name	City	State
United States	LeBonheur Children's Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View 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 20 — View 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. — View 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. — View 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 — View 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 th — View 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. — View Citation

Krichenko A, Benson LN, Burrows P, Möes 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. — View 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. — View 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. Review. — View 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. — View Citation

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

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 F — View 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. — View 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. Review. — View 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. do — View 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.0000 — View 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: 10.103 — View 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. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Valvular Injury (Safety)	Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.	6 months
Primary	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
Primary	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
Primary	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	Significant obstruction of the left pulmonary artery	Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery; =35 mmHg by echocardiogram if lung perfusion scan is not available or as determined by the interventional cardiologist based on angiographic appearance.	6 months
Secondary	Significant obstruction of the aorta	Significant obstruction of the aorta is defined as a gradient of =20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient =20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.	6 months