Clinical trials: Hypoplastic Left Heart Syndrome
Congenital Heart Disease
Evaluation of Panel Reactive Antibody in Children Following Stage I Palliation for Hypoplastic Left Heart Syndrome
The purpose of this study is to determine whether children and adolescents 8-18 years of age with HLHS and related lesions who have undergone stage I palliation during infancy using an allograft patch demonstrate continued…
- Trial name
- NCT01135485
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of Pennsylvania
Congenital Heart Defects, Hypoplastic Left Heart Syndrome
Cerebral Perfusion During Neonatal Cardiac Surgery
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA).
- Conditions
- Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation
- Trial name
- NCT01032876
- Testing
- Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Where
- Netherlands
- Volunteers
- 37 people
- Sponsor
- UMC Utrecht
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
Hypoplastic Left Heart Syndrome
SVRII Family Factors Study
The purpose of this study is to learn about the relationship between family factors and developmental and psychosocial outcomes in children with congenital heart disease at 6 years of age.
- Trial name
- NCT01582529
- Where
- 11 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Medical College of Wisconsin
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Genetic Determinants of Congenital Heart Disease Outcomes
The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery.
- Conditions
- Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, d-Transposition of the Great Arteries
- Trial name
- GECHO (NCT01656941)
- Where
- 5 sites in United States, Australia
- Volunteers
- 250 people
- Sponsor
- University of Michigan
Hypoplastic Left Heart Syndrome (HLHS), Aortic Arch Hypoplasia
Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch
Vascular Reconstruction is one of the most challenging areas of surgery, the surgeon has to create a completely watertight reconstruction without any narrowing or deformity that will restore normal flow characteristics, even at…
- Trial name
- NCT06853054
- Testing
- Personalized patch template
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
HLHS
Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)
This study is designed to assess the safety, tolerability, and efficacy of Lomecel-B as an adjunct therapy to the standard stage II (BDCPA) surgical intervention for HLHS. Lomecel-B will be delivered via intramyocardial injections
- Trial name
- ELPIS (NCT03525418)
- Testing
- Longeveron Mesenchymal Stem Cells
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Longeveron Inc.
Congenital Heart Disease
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
- Trial name
- T4G RCT (NCT04702373)
- Testing
- passive range of motion exercise therapy
- Where
- 10 sites in United States, Canada
- Volunteers
- 144 people
- Sponsor
- Carelon Research
Transfusional Iron Overload, Transfusional Hemosiderosis
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a…
- Trial name
- CORDELIA (NCT00600938)
- Testing
- Core Study: Deferasirox, Core Study: Deferoxamine, Extension: deferoxamine to deferasirox
- Where
- 21 sites in Canada, China and 9 more
- Volunteers
- 197 people
- Sponsor
- Novartis Pharmaceuticals
Heart Defects
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary…
- Trial name
- SVRIII (NCT02455531)
- Volunteers
- 237 people
- Sponsor
- Carelon Research
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
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, Coarctation of Aorta
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative…
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia
- Trial name
- NCT06768008
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Beijing Anzhen Hospital
Heart Disease
Sildenafil in Single Ventricle Patients
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance.
- Trial name
- NCT01169519
- Testing
- Sildenafil by injection
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Hypoplastic Left Heart Syndrome
Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may have an impact on development.
- Trial name
- NIRS-ND (NCT00464100)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Hypoplastic Left Heart Syndrome
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).
- Trial name
- NCT06342999
- Testing
- Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter, Trek RX and Mini Trek RX Coronary Dilatation Catheter
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mauro H. Schenone
Hypoplastic Left Heart Syndrome
Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome
Further study details as provided by Duke University: Purpose: To evaluate the feasibility and safety of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome…
- Trial name
- NCT01445041
- Testing
- Autologous Umbilical Cord Blood
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Michael Cotten
Tetralogy of Fallot (TOF), Hypoplastic Left Heart Syndrome (HLHS)
3D Modalities for Medical Student Education of Congenital Heart Disease
The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are: 1.
- Trial name
- NCT07295730
- Testing
- 3D-printed heart models and augmented reality
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Case Western Reserve University
Hypoplastic Left Heart, Congenital Heart Disease
Cardiac Biomarkers in Patients With Single Ventricle Physiology
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and…
- Conditions
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease
- Trial name
- NCT03678909
- Testing
- Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Baylor College of Medicine
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.