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

Inclusion Criteria4

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

Exclusion Criteria3

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

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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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