300 Participants Needed

Shunt vs Stent for Congenital Heart Disease

(COMPASS Trial)

Recruiting at 26 trial locations
AC
BC
RK
Overseen ByRachna Kumar
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Carelon Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Ductal Arterial Stent (DAS) for congenital heart disease?

Research shows that using a ductal stent (a small tube placed in the ductus arteriosus to keep it open) for congenital heart disease with duct-dependent pulmonary circulation can reduce the risk of death and complications compared to the Blalock-Taussig shunt. Additionally, patients with stents had better oxygen levels after the procedure.12345

Is the ductal stent or Blalock-Taussig shunt generally safe for humans?

Research shows that ductal stents are generally safe and may have fewer risks compared to the Blalock-Taussig shunt, including lower chances of death and complications. Stents also tend to result in better oxygen levels after the procedure.12367

How does the Ductal Arterial Stent treatment differ from other treatments for congenital heart disease?

The Ductal Arterial Stent (DAS) is a less invasive alternative to the Blalock-Taussig shunt for managing congenital heart disease with duct-dependent pulmonary circulation. It is associated with a lower risk of complications and mortality, and it improves oxygen levels more effectively than the surgical shunt.12389

What is the purpose of this trial?

COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.

Research Team

CP

Christopher Petit, MD

Principal Investigator

Columbia University

AG

Andrew Glatz, MD

Principal Investigator

Washington University School of Medicine

SP

Sara Pasquali, MD

Principal Investigator

University of Michigan

JR

Jenna Romano, MD

Principal Investigator

University of Michigan

JZ

Jeffrey Zampi, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I am 30 days old or younger at the time of my procedure.
My newborn has CHD and needs a stable blood flow to the lungs, decided by doctors to be treated with DAS or SPS.

Exclusion Criteria

My pulmonary arteries are not joined together and one comes from a duct.
I have a heart condition (PA/IVS) and need a procedure to relieve pressure in my heart.
You were born less than 34 weeks into the pregnancy.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

  • Ductal Arterial Stent
  • Systemic-to-Pulmonary Artery Shunt
Trial Overview 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.
Participant Groups
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.

Ductal Arterial Stent is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Ductal Artery Stent for:
  • Ductal-dependent pulmonary blood flow in neonates
🇪🇺
Approved in European Union as Ductal Artery Stent for:
  • Ductal-dependent pulmonary blood flow in neonates

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carelon Research

Lead Sponsor

Trials
76
Recruited
125,000+

HealthCore-NERI

Lead Sponsor

Trials
73
Recruited
111,000+

Pediatric Heart Network

Collaborator

Trials
11
Recruited
2,400+

Findings from Research

In a study of 22 infants with duct-dependent pulmonary circulation, ductal stenting (DS) provided adequate short-term palliation after balloon valvotomy for critical pulmonary stenosis or pulmonary atresia, allowing for sufficient oxygen saturation without the need for additional interventions.
The study found that DS was also effective for infants with univentricular hearts, enabling adequate growth before undergoing the Glenn shunt procedure, although there was an interstage mortality rate of 18%, highlighting the need for careful monitoring during this critical period.
Longevity of neonatal ductal stenting for congenital heart diseases with duct-dependent pulmonary circulation.Sivakumar, K., Bhagyavathy, A., Coelho, R., et al.[2012]
In infants with ductal dependent pulmonary blood flow, PDA stenting significantly reduces the risk of mortality and complications compared to the Blalock-Taussig shunt, with a mortality risk reduction of 41% and a complication risk reduction of 48%.
PDA stenting also leads to better post-procedure outcomes, including higher oxygen saturation levels and improved Nakata index, indicating greater stability in circulation after the procedure.
Blalock-Taussig Shunt versus Ductal Stent in the Palliation of Duct Dependent Pulmonary Circulation; A Systematic Review and Metanalysis.Fakhry AbdelMassih, A., Menshawey, R., Menshawey, E., et al.[2022]
Transcatheter ductus arteriosus stenting (DS) is a safe and feasible alternative to the modified Blalock-Taussig shunt (MBTS) for providing pulmonary blood flow in infants with cyanotic congenital heart disease, with no significant difference in post-procedural outcomes or overall mortality rates between the two methods.
However, infants with single ventricle morphology had a significantly higher mortality risk compared to those with biventricular morphology, highlighting the need for careful follow-up in these patients.
Outcomes of duct stenting and modified Blalock-Taussig shunt in cyanotic congenital heart disease with duct-dependent pulmonary circulation.Lekchuensakul, S., Somanandana, R., Namchaisiri, J., et al.[2022]

References

Longevity of neonatal ductal stenting for congenital heart diseases with duct-dependent pulmonary circulation. [2012]
Blalock-Taussig Shunt versus Ductal Stent in the Palliation of Duct Dependent Pulmonary Circulation; A Systematic Review and Metanalysis. [2022]
Outcomes of duct stenting and modified Blalock-Taussig shunt in cyanotic congenital heart disease with duct-dependent pulmonary circulation. [2022]
Comparison of Outcomes at Time of Superior Cavopulmonary Connection Between Single Ventricle Patients With Ductal-Dependent Pulmonary Blood Flow Initially Palliated With Either Blalock-Taussig Shunt or Ductus Arteriosus Stent: Results From the Congenital Catheterization Research Collaborative. [2020]
Duct stenting versus modified Blalock-Taussig shunt in neonates and infants with duct-dependent pulmonary blood flow: A systematic review and meta-analysis. [2021]
Modified Blalock-Taussig shunt versus ductal stenting for palliation of cardiac lesions with inadequate pulmonary blood flow. [2013]
Trends in Ductus Arteriosus Stent Versus Blalock-Taussig-Thomas Shunt Use and Comparison of Cost, Length of Stay, and Short-Term Outcomes in Neonates With Ductal-Dependent Pulmonary Blood Flow: An Observational Study Using the Pediatric Health Information Systems Database. [2023]
Pulmonary artery growth after palliation of congenital heart disease with duct-dependent pulmonary circulation: arterial duct stenting versus surgical shunt. [2012]
Duct Stenting vs. Modified Blalock-Taussig Shunt: New Insights Learned From High-Risk Patients With Duct-Dependent Pulmonary Circulation. [2022]
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