RecruitingNCT07535203

Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure


Sponsor

Sisca Natalia Siagian

Enrollment

52 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Fontan Procedure for people with congenital heart disease (chd) and univentricular heart. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFontan Procedure

Standard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only.


Locations(1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, Indonesia

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NCT07535203


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