Clinical trials: Cardiac Defects
Heart Valve Prosthesis
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve
The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.
- Trial name
- NCT05986396
- Testing
- INSPIRIS Resilia (model 11500A)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor College of Medicine
Noonan Syndrome
French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome
This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health…
- Trial name
- NCT05308927
- Testing
- Norditropin
- Where
- 3 sites in France
- Volunteers
- 221 people
- Sponsor
- Novo Nordisk A/S
Cardiovascular Diseases, Defect, Congenital Heart
Management of Patent Ductus in Premature Infants
To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in…
- Conditions
- Cardiovascular Diseases, Defect, Congenital Heart, Ductus Arteriosus, Patent, Heart Diseases
- Trial name
- NCT00000494
- Testing
- indomethacin, surgery, cardiovascular
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Congenital Heart Disease (CHD)
Construction of a Multi-center Clinical Research Collaboration Network for Children with Congenital Heart Disease in China
This project intends to unite the representatives of typical congenital heart disease hospitals in various provinces and cities across the country to jointly establish a multi-center clinical research collaboration network for…
- Trial name
- NCT06885307
- Where
- 6 sites in China
- Volunteers
- 35,000 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Congenital Mitral Insufficiency
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurgitation.
- Trial name
- NCT06037434
- Testing
- Captopril Tablets, Metoprolol Oral Tablet, Spironolactone Tablets
- Where
- China
- Volunteers
- 122 people
- Sponsor
- China National Center for Cardiovascular Diseases
Anesthesia, General, Congenital Heart Disease
Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation
In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.
- Conditions
- Anesthesia, General, Congenital Heart Disease, Blood Gas Monitoring, Transcutaneous, Blood Gas Analysis
- Trial name
- NCT03156764
- Testing
- Qp/Qs ratio monitoring
- Where
- South Korea
- Volunteers
- 29 people
- Sponsor
- Seoul National University Hospital
Persistent Ductus Arteriosus
The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision.
- Trial name
- NCT02602054
- Testing
- Surgical treatment, Control group
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
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, Pulmonary Hypertension
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance.
- Conditions
- Single-ventricle, Pulmonary Hypertension, Univentricular Heart
- Trial name
- VU-INHIB (NCT03997097)
- Testing
- Sildenafil
- Sponsor
- University Hospital, Montpellier
Patent Ductus Arteriosus
Treating the Resistant Patent Ductus Arteriosus (PDA)
Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure.
- Trial name
- NCT00616382
- Testing
- Indomethacin, Pentoxifylline
- Where
- Israel
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
Pulmonary Regurgitation, Tetralogy of Fallot
Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22…
- Trial name
- Venus-P (NCT02590679)
- Testing
- Venues-P Valve
- Where
- 3 sites in China
- Volunteers
- 44 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Persistent Ductus Arteriosus, Complication of Prematurity
The Preterm Infants' Paracetamol Study
Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants.
- Conditions
- Persistent Ductus Arteriosus, Complication of Prematurity, Pain or Discomfort in Intensive Care of Preterm Infants
- Trial name
- PreParaS (NCT01938261)
- Testing
- paracetamol, 0.45 % saline solution
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- University of Oulu
Cardiovascular Disease
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
- Trial name
- NCT00939224
- Testing
- Model 7600 Regional Oximeter System
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Nonin Medical, Inc
Patent Ductus Arteriosus
Comparision Between Paracetamol and Ibuprofen in Closure of Patent Ductus Arteriosus
To compare efficacy and safety of paracetamol and ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT06152796
- Testing
- Paracetamol, Ibuprofen
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Assiut University
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bundle-Branch Block, Heart Septal Defects, Ventricular
Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent.
- Trial name
- NCT01480908
- Testing
- Echocardiography at rest, Echocardiography during exercise, MRI at rest
- Where
- Denmark
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
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