Clinical trials: Fontan Procedure
Congenital Disorders
Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation
Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality.
- Trial name
- NCT00266942
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Children's Healthcare of Atlanta
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Congenital Heart Disease (CHD), Univentricular Heart
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
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…
- Trial name
- NCT07535203
- Testing
- Fontan Procedure
- Where
- Indonesia
- Volunteers
- 52 people
- Sponsor
- Sisca Natalia Siagian
Prevention of Venous Thromboembolism, Congenital Heart Disease
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery…
- Conditions
- Prevention of Venous Thromboembolism, Congenital Heart Disease, Fontan Procedure, Children
- Trial name
- NCT06193863
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 61 people
- Sponsor
- Bayer
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Sildenafil After the Fontan Operation
In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation.
- Trial name
- SAFO (NCT00507819)
- Testing
- Sildenafil
- Volunteers
- 28 people
- Sponsor
- Children's Hospital of Philadelphia
Fontan Procedure, Congenital Heart Disease
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc.
- Trial name
- NCT05684562
- Testing
- Cardiopulmonary exercise test, Pulmonary function test, Respiratory muscle strength test
- Where
- Turkey (Türkiye)
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Fontan Procedure, Altitude
Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
Important advances in cardiac surgery, intensive care, and diagnostic modalities over the last decades have led to a steady growth in the number of adults with congenital heart defects.
- Trial name
- FALCON (NCT02237274)
- Testing
- High altitude exposition
- Where
- Switzerland
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Fontan Palliation, Congenital Heart Disease
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the…
- Trial name
- NCT02659462
- Testing
- Cardio Pulmonary Exercise Testing
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Cirrhosis, Liver, Gastroesophageal Varices
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and…
- Conditions
- Cirrhosis, Liver, Gastroesophageal Varices, Fontan Procedure
- Trial name
- NCT04867954
- Testing
- Ensure Plus®, Pre-clinical validation contrast enhanced MRI, Clinical validation MRI
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Fontan Procedure, Hypoplastic Left Heart Syndrome
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Trial name
- NCT01107990
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Patients
Functional Muscle Characteristics and Cardio-respiratory Interaction in Patients With Fontan Palliation
Congenital heart disease (CHD) is the most common congenital defect, affecting about 1% of newborns. Among adults surviving complex CHD, the cohort of survivors after the Fontan palliation for univentricular physiology is the…
- Trial name
- FONTANEX (NCT04151004)
- Testing
- Incremental cycling test (ICT), Constant load cycling test (CET), Incremental respiratory muscle test (IncRMET)
- Where
- Switzerland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
Heart Defects, Congenital
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to…
- Trial name
- NCT00543309
- Testing
- nesiritide, milrinone
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- John M Costello
Fontan Procedure, Fontan Circulation
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
This is a multicenter, observational, cross-sectional study designed to investigate whether a parsimonious set of low-cost, accessible functional, anthropometric, and physiological measurements can help identify multisystem…
- Trial name
- NCT07874165
- Volunteers
- 150 people
- Sponsor
- Universidad de Murcia
Fontan Palliation
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
- Trial name
- NCT05206955
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Mayo Clinic
Respiratory Muscle Weakness
Inspiratory Training in Children After Fontan
This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate.
- Trial name
- NCT06580808
- Testing
- Fontan Training Group
- Where
- Brazil
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Marfan's Syndrome
Generation of Marfan Syndrome and Fontan Cardiovascular Models Using Patient-specific Induced Pluripotent Stem Cells
Medical researchers of National Heart Centre Singapore will carry out a state-of-the-art study that examines the possibility of changing patients' own cells into multi-functional and potent stem cells called iPS cells.
- Trial name
- NCT02815072
- Testing
- Skin biopsy
- Where
- Singapore
- Volunteers
- 30 people
- Sponsor
- National Heart Centre Singapore
Congenital Heart Defects, Functional Single Ventricle
Bosentan Therapy in Children With Functional Single Ventricle
Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.
- Trial name
- NCT01662037
- Testing
- Bosentan
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Circulatory Perfusion Disorder, Congenital Heart Disease
Early Use of Vasopressin in Post-Fontan Management
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric…
- Conditions
- Circulatory Perfusion Disorder, Congenital Heart Disease, Single-ventricle
- Trial name
- VAMP (NCT03088345)
- Testing
- Vasopressin, Arginine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Univentricular Heart
Prospective Evaluation of Univentricular Hearts
Univentricular heart defects are among the most complex congenital malformations. The treatment of these patients usually includes 3 operations and accompanying diagnostics, some of which are invasive, within the first 3 to 4…
- Trial name
- NCT05620030
- Testing
- Univentricular Heart
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Tricuspid Atresia, Heart Defects, Congenital
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure
OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure. II.
- Trial name
- NCT00004828
- Testing
- liothyronine I 131
- Volunteers
- 28 people
- Sponsor
- FDA Office of Orphan Products Development