Fontan Procedure
Treatment for Congenital Heart Anomalies
Effectiveness
80%
Safety Score
45%
Clinical Trials
58
Participants
30K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
45
DangerousModerateSafe
Treatment Details
Time to Effect
Immediate (hemodynamic change), staged over months to years, long-term management
Treatment Duration
Staged procedures over years, lifetime specialized cardiac and multi-organ care
Evidence Quality
HIGHConfidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$500
Monitoring:$2,000
Side Effect Mgmt:$1,500
Total Annual:$4,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$60,000/QALY
QALYs Gained
10
Outcome-Based Costs
Cost per Responder
$4,705.88
Cost per Remission
$13,333.33
Fontan Procedure Outcomes
for Congenital Heart Anomalies
Efficacy Outcomes
Overall Effectiveness
+80%
Response Rate
+85%
Remission Rate
+30%
Common Side Effects
Protein-losing enteropathy
+10%
Plastic bronchitis
+5%
Arrhythmias
+20%
Liver dysfunction/cirrhosis
+15%
Thromboembolism
+10%
Heart failure/Fontan failure
+15%
Mortality
+5%
Sources:
Active Clinical Trials
3 active trials recruiting for Fontan Procedure in Congenital Heart Anomalies
Fontan Fitness Trial
NCT06918795RECRUITINGNA
200 participants
INTERVENTIONAL
Philadelphia, United States
Started: Jun 9, 2025
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
NCT05684562RECRUITING
78 participants
OBSERVATIONAL
Ankara, Turkey (Türkiye)
Started: Dec 26, 2023
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
NCT05213598RECRUITING
100 participants
OBSERVATIONAL
Bethesda, United States
Started: Sep 7, 2022
Completed Clinical Trials
13 completed trials for Fontan Procedure in Congenital Heart Anomalies
The Fontan Education Study: A Randomized Control Trial
NCT02831790COMPLETEDNA
26 participants
INTERVENTIONAL
Edmonton, Canada
Started: Jul 1, 2016
Inspiratory Training in Children After Fontan
NCT06580808COMPLETEDNA
45 participants
INTERVENTIONAL
São Paulo, Brazil
Started: Sep 27, 2017
Physical Activity in Fontan Patients
NCT00363363COMPLETEDPHASE3
64 participants
INTERVENTIONAL
Toronto, Canada
Started: Aug 1, 2006
A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass
NCT03757312COMPLETEDNA
14 participants
INTERVENTIONAL
Columbus, United States
Started: Apr 24, 2019
Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
NCT03853837COMPLETED
32 participants
OBSERVATIONAL
Rochester, United States
Started: Aug 30, 2018
Ocular and Vision Problems in Patients After Fontan Operation
NCT03170778COMPLETED
65 participants
OBSERVATIONAL
Palo Alto, United States
Started: Feb 13, 2016
The Effects of Inhaled Nitric Oxide After Fontan Operation
NCT00945529COMPLETEDPHASE2, PHASE3
21 participants
INTERVENTIONAL
Wilmington, United States
Started: Feb 1, 2008
Clinical Characteristics and Associations of the "Good Fontan" Patient
NCT03470428COMPLETED
146 participants
OBSERVATIONAL
Boston, United States
Started: Mar 5, 2018
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
NCT01292551COMPLETEDPHASE2
75 participants
INTERVENTIONAL
Aarhus, Denmark +3 more
Started: Feb 1, 2011
Fluid Balance in Children Undergoing Fontan Surgery
NCT02306057COMPLETED
39 participants
OBSERVATIONAL
Oslo, Norway
Started: Nov 1, 2014
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease
NCT04278625COMPLETED
30 participants
OBSERVATIONAL
Columbus, United States
Started: Mar 23, 2021
Bosentan Therapy in Children With Functional Single Ventricle
NCT01662037COMPLETEDPHASE2
34 participants
INTERVENTIONAL
Shanghai, China
Started: Jan 1, 2010
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
NCT00004828COMPLETEDPHASE1
28 participants
INTERVENTIONAL
Started: Dec 1, 1994
Showing 20 of 58 total trials