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The U.S. PDA Registry

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ClinicalTrials.gov Identifier: NCT04205877
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Shyam K. Sathanandam, MD, Le Bonheur Children's Hospital

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.

Condition or disease Intervention/treatment
Ductus Arteriosus, Patent Device: Transcatheter PDA Closure

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: The United States Patent Ductus Arteriosus Registry
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2030
Estimated Study Completion Date : December 1, 2031

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Registry Group
All participants will have the same data collected at the same time points.
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 :
  1. Vascular Access Complications (Safety) [ Time Frame: 6 months ]
    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.

  2. Valvular Injury (Safety) [ Time Frame: 6 months ]
    Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.

  3. Device Embolization (Safety) [ Time Frame: 6 months ]
    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.

  4. Pulmonary or Aortic Vessel Stenosis (Safety) [ Time Frame: 6 months ]
    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.

  5. Rate of Effective PDA Closure (Effectiveness) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Significant obstruction of the left pulmonary artery [ Time Frame: 6 months ]

    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.


  2. Significant obstruction of the aorta [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205877


Contacts
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Contact: Shyam K Sathanandam, MD 901-287-6380 ssathan@uthsc.edu
Contact: Jorden Cunningham, BSN 901-287-7457 jorden.cunningham@lebonheur.org

Locations
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United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Contact: Shyam K Sathanandam, MD    901-287-6380    ssathan@uthsc.edu   
Contact: Jorden Cunningham, BSN    901-287-7457    jorden.cunningham@lebonheur.org   
Sponsors and Collaborators
Le Bonheur Children's Hospital
Abbott
Investigators
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Principal Investigator: Shyam Sathanandam, MD National Principal Investigator
  Study Documents (Full-Text)

Documents provided by Shyam K. Sathanandam, MD, Le Bonheur Children's Hospital:
Study Protocol  [PDF] October 18, 2018

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

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Responsible Party: Shyam K. Sathanandam, MD, Associate Professor of Pediatrics, University of Tennessee. Director of Cath Lab, Le Bonheur Children's Hospital., Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT04205877    
Other Study ID Numbers: The U.S. PDA Registry
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A Data Management Plan (DMP) will describe procedures used for data review, database cleaning, and issuing and resolving data queries. If appropriate, the DMP may be updated throughout the clinical investigation duration. All revisions will be tracked and document controlled. Subject data will be captured in a validated electronic data capture (EDC) system. Only authorized site personnel will be permitted to enter the CRF data through the EDC system. An electronic audit trail will be used to track any subsequent changes of the entered data.
Supporting Materials: Study Protocol
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities