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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

Tracking Information
First Submitted Date December 16, 2019
First Posted Date December 20, 2019
Last Update Posted Date December 20, 2019
Estimated Study Start Date January 1, 2020
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 17, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The U.S. PDA Registry
Official Title The United States Patent Ductus Arteriosus Registry
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Registry Group
All participants will have the same data collected at the same time points.
Intervention: Device: Transcatheter PDA Closure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 17, 2019)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2031
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Shyam K Sathanandam, MD 901-287-6380 ssathan@uthsc.edu
Contact: Jorden Cunningham, BSN 901-287-7457 jorden.cunningham@lebonheur.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04205877
Other Study ID Numbers The U.S. PDA Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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
Supporting Materials: 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.
Responsible Party Shyam K. Sathanandam, MD, Le Bonheur Children's Hospital
Study Sponsor Le Bonheur Children's Hospital
Collaborators Abbott
Investigators
Principal Investigator: Shyam Sathanandam, MD National Principal Investigator
PRS Account Le Bonheur Children's Hospital
Verification Date December 2019