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
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 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
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.
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
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
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
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Fluid Balance in Children Undergoing Fontan Surgery
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure.
- Trial name
- NCT02306057
- Testing
- Pre BCPC, Pre TCPC, BCPC surgery
- Where
- Norway
- Volunteers
- 39 people
- Sponsor
- Oslo University Hospital
Hypoplastic Left Heart Syndrome
A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle.
- Trial name
- NCT01708863
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Timothy J Nelson, MD, PhD
Hypoplastic Left Heart Syndrome (HLHS)
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between…
- Trial name
- NPC-QIC (NCT02852031)
- Testing
- Collaborative Learning Network
- Where
- 63 sites in United States, Canada and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Hypoplastic Left Heart Syndrome
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.
The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B.
- Trial name
- ELPIS II (NCT04925024)
- Testing
- Lomecel-B medicinal signaling cells
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Longeveron Inc.
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy
This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days…
- Trial name
- NCT04181255
- Testing
- Curosurf
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Michigan
Hypoplastic Left Heart, Surgery
NIRS in Neonatal Cardiac Surgery
Due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery.
- Trial name
- NCT00166101
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Emory University
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
Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome
This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome…
- Trial name
- ELPIS (NCT02398604)
- Testing
- Allo-hMSCs
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Longeveron Inc.
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
Hypoplastic Left Heart Syndrome
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with…
- Trial name
- NCT03779711
- Testing
- Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
- Where
- 8 sites in United States
- Volunteers
- 95 people
- Sponsor
- Timothy J Nelson, MD, PhD
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
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