The U.S. PDA Registry

December 17, 2019 updated by: Shyam K. Sathanandam, MD, Le Bonheur Children's Hospital

The United States Patent Ductus Arteriosus Registry

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 months (Child)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Le Bonheur Children's Hospital

Collaborators

Abbott

Investigators

  • Principal Investigator: Shyam Sathanandam, MD, National Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

December 1, 2031

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The U.S. PDA Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Data will become available when it is collected and added to the national database. It will be available for 12 years.

IPD Sharing Access Criteria

Investigators will submit proposal to request data to the Proposal Review Committee. If approved, de-identified data will be shared.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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