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

Study acronym: SVRIII
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Results first posted: Nov 10, 2025v11 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 264 to 237
    • Study completion date: Jun 2025 to Dec 2025
    • Secondary endpoints revised (6)
  2. 2 versions Re-verified since Mar 14, 2022, no change to tracked fieldsv9-v10
  3. Trial status: Enrolling by Invitation to Active, Not Recruitingv8
  4. Primary completion date: Jun 2020 to Oct 2020v7
  5. 4 versions Re-verified since Sep 27, 2016, no change to tracked fieldsv3-v6
  6. Secondary endpoints revised (6)v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02455531
Lead Sponsor Carelon Research
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Heart Defects
Enrollment 237 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov