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Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

RECRUITINGSponsored by Sisca Natalia Siagian
Actively Recruiting
SponsorSisca Natalia Siagian
Started2025-01-01
Est. completion2027-03-01
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07535203

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

Healthy volunteers accepted
Inclusion Criteria:

* Diagnosed cyanotic CHD
* Univentricular heart physiology
* Planned staged palliation including Fontan procedure
* Informed consent obtained (patient or guardian)

Exclusion Criteria:

* Refusal to participate
* Incomplete clinical data
* Inability to complete follow-up

Conditions3

Congenital Heart Disease (CHD)Heart DiseaseUniventricular Heart

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