Clinical trials: Single Ventricle Cardiac Anomaly
Failing Fontan Physiology, Failing Fontan
The Destination Therapy Evaluation for Failing Fontan Study
Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe Study) is to perform a single center physician-investigator led feasibility study to initiate examination of the safety and efficacy of…
- Conditions
- Failing Fontan Physiology, Failing Fontan, Single-ventricle, Single-ventricle Fontan
- Trial name
- DEFINe (NCT01149603)
- Testing
- HeartMate II Ventricular Assist Device
- Where
- United States
- Sponsor
- Timothy Icenogle, MD
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
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
Pediatric ALL, Congenital Heart Disease
Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities.
- Conditions
- Pediatric ALL, Congenital Heart Disease, Single-ventricle, Biventricular Congestive Heart Failure
- Trial name
- NCT05034354
- Testing
- Remote physiological monitoring
- Where
- Canada
- Volunteers
- 23 people
- Sponsor
- University of Alberta
Congenital Heart Disease, Single-ventricle
Ventripoint Single Ventricle Study
This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.
- Trial name
- NCT05262907
- Testing
- Transthoracic Echocardiogram or Cardiac MRI, Ventripoint Echocardiogram
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Single-ventricle, Fontan Procedure
Exercise Capacity in Patients With Fontan Procedure
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly.
- Trial name
- NCT05063903
- Testing
- Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
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.
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, Single Ventricle
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement.
- Trial name
- NCT02614664
- Testing
- NIRS
- Where
- United States
- Sponsor
- Roby Sebastian
Congenital Heart Defects, Functional Single Ventricle
Bosentan Therapy in Children With Functional Single Ventricle
Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.
- Trial name
- NCT01662037
- Testing
- Bosentan
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease, Single-ventricle
Clinical Characteristics and Associations of the "Good Fontan" Patient
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse…
- Trial name
- NCT03470428
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Boston Children's Hospital
Congenital Heart Defect
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following…
- Trial name
- NCT02860702
- Testing
- Human Milk Derived Fortifier, Human/Bovine Milk
- Where
- 12 sites in United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Congenital Heart Disease
Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single…
- Trial name
- NCT02549625
- Testing
- Autologous Bone Marrow-derived Mononuclear Cells
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Timothy J Nelson, MD, PhD
Hypoplastic Left Heart Syndrome, Single Ventricle
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
- Trial name
- TICAP (NCT01273857)
- Testing
- Autologous cardiac progenitor cell transplantation, staged shunt procedure
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Okayama University
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
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
Single-ventricle, Stenosis
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years…
- Trial name
- NCT07073612
- Testing
- Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Los Angeles
Congenital Heart Disease, Single Ventricle
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation Postoperative in Fontan Patients: Effects of Exercise Training
Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles.
- Conditions
- Congenital Heart Disease, Single Ventricle, Univentricular Heart
- Trial name
- NCT02283255
- Testing
- Aerobic Exercise Training, Inspiratory Muscle Training, No Exercise Training
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
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