Clinical trials: Single Ventricle
Dopamine, Protein-Losing Enteropathies
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE).
- Conditions
- Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph
- Trial name
- NCT03322345
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Pediatric Brain Tumors, Glioma
AI-Assisted MRI Molecular Subtyping in Pediatric Brain Tumors
This multicenter observational cohort study aims to develop and validate an artificial intelligence (AI)-assisted diagnostic system for preoperative molecular subtyping of pediatric brain tumors using routine magnetic resonance…
- Conditions
- Pediatric Brain Tumors, Glioma, Medulloblastoma, Ependymoma
- Trial name
- NCT07703605
- Volunteers
- 1,400 people
- Sponsor
- Huashan 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
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Safety and Efficacy of Emergent TAVI in Patients With Severe AS
This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies
- Trial name
- NCT05528211
- Volunteers
- 10 people
- Sponsor
- Qilu Hospital of Shandong University
Fontan Procedure, Hypoplastic Left Heart Syndrome
Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients
In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- Trial name
- NCT00974025
- Testing
- Vitamin C
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Hypoplastic Left Heart Syndrome
Cerebral Anatomy, Hemodynamics and Metabolism
Single ventricle lesions are the leading cause of illness and death from congenital heart disease. The modified Fontan Operation is the corrective surgery for these lesions.
- Trial name
- NCT02919956
- Testing
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Congenital Heart Disease
Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood…
- Trial name
- NCT01134302
- Testing
- Norwood management strategy, Hybrid Strategy
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- The Hospital for Sick Children
Tetralogy of Fallot, Hypoplastic Left Heart Syndrome
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload.
- Conditions
- Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital
- Trial name
- NCT04581668
- Testing
- Two ventilation periods with two different modes: conventional ventilation followed by NAVA.
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- St. Justine's Hospital
Congenital Heart Disease
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
- Trial name
- DGX01 (NCT03877965)
- Testing
- Digoxin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Christoph P Hornik, MD MPH
Aortic Stenosis, Aortic Insufficiency
CardioCel Tri-leaflet Repair Study
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
- Trial name
- CTRS (NCT02629328)
- Testing
- CardioCel
- Where
- Belgium
- Volunteers
- 28 people
- Sponsor
- Anteris Technologies Ltd.
Congenital Heart Defect, Single-ventricle
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow.
- Conditions
- Congenital Heart Defect, Single-ventricle, Coarctation of Aorta, Atrioventricular Canal
- Trial name
- NCT04106479
- Testing
- NIRS evaluation
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
HLH - Hypoplastic Left Heart Syndrome, DORV
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
- Conditions
- HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia
- Trial name
- TEVG-2 (NCT04467671)
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Congenital Heart Defect, Hypoplastic Left Heart Syndrome
Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
Single ventricular (SV) heart was a uniformly fatal condition before the advances in surgical treatment in 1980. In the present era, 5-year survival rate with SV is 75%, with some centers, including the Stollery Children's…
- Conditions
- Congenital Heart Defect, Hypoplastic Left Heart Syndrome, Physical Activity
- Trial name
- MedBike (NCT04056416)
- Testing
- MedBIKE
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
Hypoplastic Left Heart Syndrome, Obstructive Sleep Apnea Syndrome
Sleep Disordered Breathing in Children With Single Ventricle Physiology
This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with: 1.
- Conditions
- Hypoplastic Left Heart Syndrome, Obstructive Sleep Apnea Syndrome, Single Ventricle Physiology
- Trial name
- NCT00156455
- Where
- United States
- Sponsor
- University of Rochester
Heart Disease, Congenital, Single Ventricle
Single Ventricle Outcome
The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.
- Conditions
- Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome
- Trial name
- NCT00308217
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Heart Defects, Congenital
Long-term Survival After Single-ventricle Palliation
A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively.
- Trial name
- NCT03356574
- Testing
- Single-ventricle palliation surgery
- Where
- 2 sites in Sweden
- Volunteers
- 800 people
- Sponsor
- Karolinska University Hospital