CompletedNot Applicable

Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

United States555 participantsStarted 2005-05

Plain-language summary

This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly * Planned Norwood procedure * Informed consent of parent(s) or legal guardian Exclusion Criteria: * Single, morphologic left ventricle anomaly * Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible * Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint

What they're measuring

Proportion of Patients Who Died or Received a Heart Transplant

Timeframe: Measured at 12 months

Trial details

NCT IDNCT00115934

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2010-09-14

View on ClinicalTrials.gov More Heart Defects, Congenital trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.