Clinical trials: Fontan Operation
Heart Defects, Congenital
Colloid Osmotic Pressure in Patients With Fontan Circulation
Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid…
- Trial name
- NCT02443662
- Testing
- Catheterization
- Where
- Norway
- Volunteers
- 12 people
- Sponsor
- Oslo University Hospital
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
Congenital Heart Disease, Fontan Operation
The Role of the Pulmonary Vasculature in the Fontan Circulation
This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients. Objectives: Determine the effect of pulmonary vasodilatation on indexed cardiac output during…
- Conditions
- Congenital Heart Disease, Fontan Operation, Pulmonary Vascular Resistance, Pulmonary Vascular Remodeling
- Trial name
- NCT02414321
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
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
Fontan Procedure
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation.
- Trial name
- NCT02966002
- Testing
- Aspirin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Michigan
Single-ventricle
Re-Energize Fontan
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high.
- Trial name
- NCT04195451
- Testing
- Live-Video-Supervised Exercise Intervention, Usual Care then Live-Video Supervised Exercise Intervention
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stanford University
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Liver Fibrosis
Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.
- Trial name
- NCT03539757
- Testing
- Non-Contrast Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Single Ventricle Defect
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
This study seeks to determine cerebral blood flow changes in single ventricle patients during staged surgical reconstruction as compared with normal children.
- Trial name
- CBF (NCT02135081)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Disorders
Spironolactone in Patients With Single Ventricle Heart
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions.
- Trial name
- NCT00211081
- Testing
- Spironolactone (drug)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
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, 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
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
Tricuspid Atresia, Hypoplastic Left Heart Syndrome
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
- Conditions
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- Trial name
- BHFSVP (NCT00571233)
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of California, San Francisco
Pleural Effusion, Single-ventricle
Use of Vasopressin Following the Fontan Operation
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
- Trial name
- NCT02975999
- Testing
- Vasopressin, Normal Saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Wake Forest University Health Sciences
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Congenital Heart Disease
Microcirculation and Vascular Function After Fontan Surgery
Fontan Surgery is done for children with only one working lower chamber of the heart called the 'Single Ventricle'. This surgery involves making connections between the two big veins that drain oxygen deficient blood to the heart…
- Trial name
- MICROFON (NCT05683067)
- Testing
- Hand Held Capillary Microscopy, Mobile 'O' Graph, quality of life using questionnaires
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Leicester
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