Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07535203

Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

Sponsor: Sisca Natalia Siagian

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

52

Start Date

2025-01-01

Completion Date

2027-06

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

PROCEDURE

Fontan 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