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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

Must not have

Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin).

Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 days old or younger at the time of my procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pulmonary arteries are not joined together and one comes from a duct.

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I have a heart condition (PA/IVS) and need a procedure to relieve pressure in my heart.

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My lung arteries are severely narrowed, confirmed by a CT scan or MRI.

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I am expected to undergo a specific heart or lung procedure before or along with DAS or SPS, excluding certain artery treatments.

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I have a condition where two blood vessels in my heart did not close after birth.

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My birth weight was under 2 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Morbidity - disease rate

Secondary study objectives

Days Alive out of Hospital

Freedom from Adverse Events

Global Rank Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met