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Stent

Shunt vs Stent for Congenital Heart Disease (COMPASS Trial)

N/A
Recruiting
Research Sponsored by Carelon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≤ 30 days at time of index procedure (DAS or SPS).
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

COMPASS Trial 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.

Who is the study for?
The COMPASS trial is for newborns with certain heart defects needing a stable blood flow to the lungs. It's open to babies 30 days old or younger, without severe additional health issues, genetic anomalies that affect survival, or those requiring other major interventions alongside the tested procedures.Check my eligibility
What is being tested?
This study compares two ways to improve lung blood flow in newborns with heart defects: either placing a stent in the ductal artery or creating a shunt between systemic and pulmonary arteries. Babies will be randomly assigned to one of these treatments and tracked for their first year.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications related to heart surgery in infants such as infection, bleeding, reaction to anesthesia, and issues related to device placement like blockage or dislocation.

COMPASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 30 days old or younger at the time of my procedure.

COMPASS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morbidity - disease rate
Secondary outcome measures
Days Alive out of Hospital
Freedom from Adverse Events
Global Rank Score

COMPASS Trial Design

2Treatment groups
Experimental Treatment
Group I: Systemic-to-Pulmonary Artery ShuntExperimental Treatment1 Intervention
Surgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.
Group II: Ductal Artery StentExperimental Treatment1 Intervention
Transcatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team.

Find a Location

Who is running the clinical trial?

Carelon ResearchLead Sponsor
73 Previous Clinical Trials
216,455 Total Patients Enrolled
Pediatric Heart NetworkOTHER
10 Previous Clinical Trials
2,106 Total Patients Enrolled
HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,433 Total Patients Enrolled

Media Library

Ductal Arterial Stent (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT05268094 — N/A
Congenital Heart Disease Research Study Groups: Ductal Artery Stent, Systemic-to-Pulmonary Artery Shunt
Congenital Heart Disease Clinical Trial 2023: Ductal Arterial Stent Highlights & Side Effects. Trial Name: NCT05268094 — N/A
Ductal Arterial Stent (Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268094 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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

"Clinicaltrials.gov 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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
2022. "Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268094.
~150 spots leftby Mar 2026
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