Clinical trials: Single Ventricle
Anemia
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low.
- Trial name
- NCT00459225
- Testing
- Iron (ferrous sulfate)
- Where
- United States
- Sponsor
- Emory University
Single-ventricle, Posttraumatic Stress Disorder
The PaTHS Descriptive Correlational Longitudinal Study
The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease.
- Conditions
- Single-ventricle, Posttraumatic Stress Disorder, Psychosocial Impairment
- Trial name
- PaTHS (NCT04785482)
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Mercy Hospital Kansas City
Single Ventricle
Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients
This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation.
- Trial name
- NCT01291069
- Testing
- Tadalafil Citrate, Sugar pill
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Utah
Single Ventricle, Fontan
Effect of Carvedilol on Exercise Performance in Fontan Patients
This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart operation. All participants will receive carvedilol and placebo for 12 weeks.
- Trial name
- NCT02946892
- Testing
- Carvedilol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Texas Southwestern Medical Center
Single-ventricle, Heart Diseases
Colchicine in Postoperative Fontan Patients
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the…
- Trial name
- CPFP (NCT03575572)
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
CHD - Congenital Heart Disease, Single Ventricle Heart Disease
PRecision Integrated Saturation Monitor
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients.
- Trial name
- PRISM (NCT07686341)
- Testing
- vital sign monitoring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Le Bonheur Children's 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
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
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
Heart Defects
Single Ventricle Reconstruction Extension Study (SVR II) - Pediatric Heart Network
The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation).
- Trial name
- SVRII (NCT02110823)
- Volunteers
- 325 people
- Sponsor
- Carelon Research
Congenital Heart Disease (CHD), Univentricular Heart
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged…
- Trial name
- NCT07535203
- Testing
- Fontan Procedure
- Where
- Indonesia
- Volunteers
- 52 people
- Sponsor
- Sisca Natalia Siagian
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
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Aortic Valve Stenosis, Structural Valve Deterioration
Single Perclose Escalation Technique for Vascular Closure in TAVR
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end…
- Conditions
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- Trial name
- NCT05836311
- Testing
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
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
Univentricular Heart
Prospective Evaluation of Univentricular Hearts
Univentricular heart defects are among the most complex congenital malformations. The treatment of these patients usually includes 3 operations and accompanying diagnostics, some of which are invasive, within the first 3 to 4…
- Trial name
- NCT05620030
- Testing
- Univentricular Heart
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Single-ventricle, Congenital Heart Disease
Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex.
- Trial name
- VU3D (NCT05118152)
- Where
- France
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Single-ventricle
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical…
- Trial name
- NCT07087782
- Testing
- Fortini formula, Standard Nutritional Care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Driscoll Children's Hospital
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