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Device

Registry Group for Patent Ductus Arteriosus

N/A
Waitlist Available
Led By Shyam Sathanandam, MD
Research Sponsored by Le Bonheur Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device Embolization (Safety)
Pulmonary or Aortic Vessel Stenosis (Safety)
Rate of Effective PDA Closure (Effectiveness)
+2 more
Secondary outcome measures
Significant obstruction of the aorta
Significant obstruction of the left pulmonary artery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Registry GroupExperimental Treatment1 Intervention
All participants will have the same data collected at the same time points.

Find a Location

Who is running the clinical trial?

AbbottIndustry Sponsor
752 Previous Clinical Trials
473,162 Total Patients Enrolled
Le Bonheur Children's HospitalLead Sponsor
27 Previous Clinical Trials
5,016,049 Total Patients Enrolled
Shyam Sathanandam, MDPrincipal InvestigatorNational Principal Investigator
~2625 spots leftby Jan 2030
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