CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Extracardiac Fontan +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03503032
NCT03503032N/ACompleted
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Fenestrated Vs Non Fenestrated Extra-Cardiac Total Cavo-pulmonary Connection in Patients With Standard Preoperative Risk Profiles, A Prospective Randomized Study

King Faisal Specialist Hospital & Research Center·observational·Posted Apr 19, 2018·Updated Apr 18, 2023

In Brief

An observational study evaluating Extracardiac Fontan and Fontan fenestration for Fontan Procedure. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFontan Procedure
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 19, 2018
Enrollment StartApr 1, 2023
Primary CompletionApr 12, 2023
TodayJul 2, 2026
Enrollment to primary: 11 daysPosted 8.2 years ago

Interventions

Extracardiac Fontanprocedure

Extracardiac Fontan (Total cavo-pulmonary connection) will be constructed with a tube graft from the inferior vena cava to the pulmonary artery \[applied to both arms\]

Fontan fenestrationprocedure

Fontan fenestration created as a single 3 to 6mm communication between fontan channel and pulmonary venous atrium \[Fenestrated arm\]