Active — Not RecruitingNot Applicable

Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)

United States300 participantsStarted 2022-06-02

Plain-language summary

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.

Who can participate

Age range1 Day – 30 Days

SexALL

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Inclusion criteria

✓. Neonates with Congenital Heart Disease (CHD) and ductal-dependent pulmonary blood flow requiring only a stable source of pulmonary blood flow as the initial palliation, for whom the clinical decision is made at the enrolling center that this is best achieved by either DAS or SPS.
✓. Age ≤ 30 days at time of index procedure (DAS or SPS).

What they're measuring

Morbidity and/or Mortality Endpoint

Timeframe: 1 year

Trial details

NCT IDNCT05268094

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

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