Systemic-to-Pulmonary Artery Shunt for Congenital Heart Disease

Phase-Based Progress Estimates
Le Bonheur Children's Hospital, Memphis, TNCongenital Heart DiseaseSystemic-to-Pulmonary Artery Shunt - Procedure
1 - 30
All Sexes
What conditions do you have?

Study Summary

This trial is testing whether a systemic-to-pulmonary artery shunt or ductal artery stent is better for treating babies with ductal-dependent pulmonary blood flow.

Eligible Conditions
  • Congenital Heart Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
Days Alive out of Hospital
Freedom from Adverse Events
Global Rank Score
Morbidity - disease rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Ductal Artery Stent
1 of 2
Systemic-to-Pulmonary Artery Shunt
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Systemic-to-Pulmonary Artery Shunt · No Placebo Group · N/A

Ductal Artery Stent
Experimental Group · 1 Intervention: Ductal Arterial Stent · Intervention Types: Device
Systemic-to-Pulmonary Artery Shunt
Experimental Group · 1 Intervention: Systemic-to-Pulmonary Artery Shunt · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Pediatric Heart NetworkOTHER
10 Previous Clinical Trials
2,106 Total Patients Enrolled
HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,483 Total Patients Enrolled
Jenna Romano, MDStudy ChairUniversity of Michigan
Christopher Petit, MDStudy ChairColumbia University
Jeffrey Zampi, MDStudy ChairUniversity of Michigan
Andrew Glatz, MDStudy ChairWashington University School of Medicine
Sara Pasquali, MDStudy ChairUniversity of Michigan

Eligibility Criteria

Age 1 - 30 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Newborns who have a heart condition called Congenital Heart Disease (CHD) that requires a stable source of pulmonary blood flow can be included in the study if their healthcare provider decides the best way to achieve this is by either DAS or SPS.

Frequently Asked Questions

Might I be qualified to participate in this medical study?

"This clinical trial is enrolling 300 neonates, who are no older than 30 days of age and have Congenital Heart Disease. Optimally, these infants require only a stable pulmonary circulation to be palliated: either through Ductal-Associated Stenting (DAS) or by Surgical Pulmonary Shunt Placement (SPS)." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are actively participating in this research endeavor?

"The list of participating medical centres in this clinical trial includes New York Presbyterian Hospital/Columbia University Irving Medical Center, Children's Hospital Los Angeles, and the University of Alabama at Birmingham. Additionally, there are 25 other clinics facilitating enrollment across the United States." - Anonymous Online Contributor

Unverified Answer

What is the scope of participation in this experiment?

"This clinical trial requires 300 eligible patients to partake in the research. Those interested may sign up at New York Presbyterian Hospital/Columbia University Irving Medical Center located in New York, NY and Children's Hospital Los Angeles based out of California." - Anonymous Online Contributor

Unverified Answer

Are senior citizens eligible for inclusion in this research?

"The target demographic of this experiment are individuals between 1 Day and 30 Days years old." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities for participation in this experiment at the moment?

" reveals that this trial is still in progress, with the original post date being June 2nd 2022 and the most recent edit on November 21st of the same year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.