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The U.S. PDA Registry

NCT04205877 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2019-12-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Le Bonheur Children's Hospital

    lead OTHER

Principal Investigators

  • Shyam Sathanandam, MD · National Principal Investigator

Eligibility

Min Age
3 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2030-01-01
Completion
2031-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205877 on ClinicalTrials.gov