Clinical trials: Cardiac Defects
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)
Growth Hormone Deficiency, Turner Syndrome
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
- Trial name
- NCT00256126
- Testing
- Saizen
- Where
- 13 sites in Argentina, Australia and 11 more
- Volunteers
- 318 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Long QT Syndrome
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes
Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation.
- Trial name
- NCT02513940
- Testing
- Testosterone, Progesterone, Ibutilide
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Indiana University
Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery.
- Conditions
- Transposition of the Great Vessels, Hypoplastic Left Heart Syndrome, Oxygen Consumption Based Assessment of Hemodynamics
- Trial name
- Oxy-CAHN (NCT02184169)
- Testing
- General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments, Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Boston Children's Hospital
Pulmonary Stenosis, Pulmonary Regurgitation
Pulmonary Artery Repair With Covered Stents
The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary…
- Conditions
- Pulmonary Stenosis, Pulmonary Regurgitation, Tetralogy of Fallot
- Trial name
- PARCS (NCT01824160)
- Testing
- Repair of RV-PA Conduit Disruption
- Where
- 38 sites in United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Congenital Heart Disease
Paravertebral Nerve Blocks in Neonates
This study is a prospective, randomized, non-blinded clinical trial examining the use of paravertebral peripheral nerve block in the neonatal and infant populations.
- Trial name
- NCT03408340
- Testing
- Paravertebral Nerve Block, Standard of Care Anesthesia
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Emory University
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning…
- Conditions
- Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Aortic Arch Hypoplasia or Interruption
- Trial name
- NCT00513240
- Testing
- Erythropoetin, Normal saline
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Baylor College of Medicine
Congenital Heart Disease
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
- Trial name
- RUBATO (NCT03153137)
- Testing
- Macitentan 10 mg
- Where
- 32 sites in United States, Australia and 10 more
- Volunteers
- 142 people
- Sponsor
- Actelion
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.
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Turner Syndrome, Hypogonadism
Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism
Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female.
- Conditions
- Turner Syndrome, Hypogonadism, Premature Ovarian Failure
- Trial name
- NCT00837616
- Testing
- 17 B estradiol orally, 17 B estradiol
- Where
- 3 sites in United States, Chile
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Immune Deficiency Disorders, Severe Combined Immunodeficiency
Immune Disorder HSCT Protocol
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders.
- Conditions
- Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia
- Trial name
- NCT01821781
- Testing
- Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Long QT Syndrome
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the primary care environment.
- Trial name
- NCT04441892
- Testing
- QTc Meter
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Mayo Clinic
Chronic Ischemic Heart Disease, Left Ventricular Dysfunction
Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments.
- Conditions
- Chronic Ischemic Heart Disease, Left Ventricular Dysfunction, Angina, Ischemic Cardiomyopathy
- Trial name
- NCT00824005
- Testing
- Adult stem cells
- Where
- 5 sites in United States
- Volunteers
- 92 people
- Sponsor
- The University of Texas Health Science Center, Houston
Single Ventricle Heart Disease After Fontan Surgery
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation.
- Trial name
- NCT01815502
- Testing
- Cardiac catheterization
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Congenital Heart Defect
The Effects of Inhaled Nitric Oxide After Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance.
- Trial name
- NCT00945529
- Testing
- inhaled nitric oxide (iNO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ellen Spurrier
Patent Ductus Arteriosus, Surgery
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach.
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Trial name
- PDA:TOLERATE (NCT01958320)
- Testing
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- Where
- 18 sites in United States, Sweden and 2 more
- Volunteers
- 202 people
- Sponsor
- University of California, San Francisco