Clinical trials: Heart Defects, Congenital
- Condition Heart Defects, Congenital
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Heart Defects, Congenital, Hypertension, Pulmonary
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Trial name
- NCT00335244
- Testing
- L-citrulline
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Growth Failure, Congenital Heart Disease
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
This study is a prospective, open-label, multi-site, growth, safety and tolerance study to evaluate a NF (New Formula). A minimum of 45 evaluable infants with confirmed growth failure will be enrolled.
- Trial name
- NCT03563391
- Testing
- New Infant Formula
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nutricia North America
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Heart Defects, Congenital
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.
- Trial name
- CLARINET LT (NCT00833703)
- Testing
- Clopidogrel
- Where
- 15 sites in United States, Brazil and 13 more
- Volunteers
- 49 people
- Sponsor
- Sanofi
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Congenital Heart Disease, Tetralogy of Fallot
Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)
The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.
- Trial name
- NCT01762124
- Testing
- Native Outflow Tract TPV
- Where
- 3 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Medtronic Heart Valves
Syncope, Pediatric
Pediatric Adhesion and New Dermal Approach Study
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease
- Trial name
- PANDA (NCT07118124)
- Testing
- Zio monitor
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- iRhythm Technologies, Inc.
Hereditary Transthyretin-mediated (hATTR) Amyloidosis, Polyneuropathy
Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.
- Trial name
- NCT05040373
- Where
- 7 sites in United States, France and 5 more
- Volunteers
- 10 people
- Sponsor
- Alnylam Pharmaceuticals
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
Congenital Heart Malformations
Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation.
- Trial name
- NCT07381530
- Testing
- heart will be treated with Custodiol-N, heart will be treated with Custodiol
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Pulmonary Arterial Hypertension
Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.
- Trial name
- MAESTRO (NCT01743001)
- Testing
- Macitentan 10 mg
- Where
- 55 sites in United States, Austria and 19 more
- Volunteers
- 226 people
- Sponsor
- Actelion
Genetic Disorder, Turner Syndrome
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height.
- Trial name
- NCT01518062
- Testing
- somatropin, oestrogen
- Where
- Netherlands
- Volunteers
- 65 people
- Sponsor
- Novo Nordisk A/S
Genetic Disorder, Turner Syndrome
Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome
This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.
- Trial name
- NCT01710696
- Testing
- 17-beta estradiol
- Where
- 28 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Congenital Heart Disease
ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.
- Trial name
- NCT06078943
- Testing
- method comparison
- Where
- United States
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Radiometer Medical ApS
Transfusional Iron Overload, Transfusional Hemosiderosis
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a…
- Trial name
- CORDELIA (NCT00600938)
- Testing
- Core Study: Deferasirox, Core Study: Deferoxamine, Extension: deferoxamine to deferasirox
- Where
- 21 sites in Canada, China and 9 more
- Volunteers
- 197 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical