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Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

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Summary

NIH registered a prospective cohort study (NCT07535203) comparing Fontan procedure outcomes in patients with cyanotic congenital heart disease classified by pulmonary blood flow characteristics. Fifty-two patients will be divided into oligemia and plethora groups and followed for approximately 1.5 years post-procedure to assess mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.

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What changed

NIH added a new clinical trial registration for an observational study comparing outcomes between pulmonary oligemia and pulmonary plethora in patients with univentricular heart physiology undergoing the Fontan procedure. The study will enroll 52 participants and track outcomes including mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life over approximately 1.5 years of follow-up.

Healthcare institutions conducting congenital heart disease research should note this study's focus on stratifying Fontan patients by pulmonary blood flow patterns. The study may inform future clinical decision-making regarding patient selection and risk stratification for staged palliation procedures. Patients enrolled in Fontan-related studies should discuss participation eligibility with their cardiac care teams.

Archived snapshot

Apr 17, 2026

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Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

Observational NCT07535203 Kind: OBSERVATIONAL Apr 17, 2026

Abstract

This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.

Conditions: Congenital Heart Disease (CHD), Univentricular Heart

Interventions: Fontan Procedure

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535203

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6221 Hospitals & Health Systems
Activity scope
Clinical trial registration Medical research Congenital heart disease treatment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Medical Devices

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