Clinical trials: Hypoplastic Left Heart Syndrome, open to volunteers
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
Congenital Heart Disease, Aortic Valve Stenosis
Effect of Fetal Aortic Valvuloplasty on Outcomes
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Trial name
- FASSprosp (NCT05386173)
- Testing
- Fetal aortic balloon dilatation
- Where
- 13 sites in United States, Austria and 6 more
- Volunteers
- 200 people
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
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.
Hypoplastic Left Heart Syndrome
Study of Intramyocardial Injection of Ventrix Bio Extracellular Matrix (VentriGel) to Assess the Safety and Feasibility in Pediatric Patients with Hypoplastic Left Heart Syndrome (HLHS)
The goal of this Phase I Open-Label study is to demonstrate the safety and feasibility of VentriGel injection in children with Hypoplastic Left Heart Syndrome (HLHS).
- Trial name
- NCT06461676
- Testing
- Ventrix Bio Extracellular Matrix
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
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
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with…
- Conditions
- Congenital Heart Disease, Cyanotic Congenital Heart Disease, d-Transposition of the Great Arteries, Hypoplastic Left Heart Syndrome
- Trial name
- Neuro-Moms (NCT06711666)
- Where
- 5 sites in France
- Volunteers
- 174 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Congenital Heart Disease
The Co-Op @ HeartWorks
This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD…
- Trial name
- NCT06469918
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- HeartWorks, Inc.
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
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
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela 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
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