Active — Not RecruitingNot Applicable

Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type

237 participantsStarted 2015-06

Plain-language summary

The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.

Who can participate

Age range10 Years – 12 Years

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: * All SVR study cohort members will be contacted to assess for vital status. Transplant free survivors will be approached to participate in the in-person assessment. Exclusion Criteria: * Patients who have undergone cardiac transplantation or biventricular conversion from all outcomes other than vital status. * Those with pacemakers will be excluded from the CMR, and patients \<130 cm in height will be excluded from the exercise test.

What they're measuring

RVEF at 10-12 Years on MRI

Timeframe: assessed between 10-12 years of age, an average of 53.2 days from consent

Trial details

NCT IDNCT02455531

SponsorCarelon Research

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-10

Results submitted2025-02-26

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