Clinical trials: Cardiac Defects
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Anesthesia; Adverse Effect, Congenital Heart Disease
The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic…
- Conditions
- Anesthesia; Adverse Effect, Congenital Heart Disease, Neurodevelopmental Disorders
- Trial name
- NDO (NCT03882788)
- Testing
- Isoflurane, Fentanyl (high dose), Fentanyl (low dose)
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Stanford University
Velo-cardio-facial Syndrome, Psychosis
Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with…
- Trial name
- NCT01127503
- Testing
- Metyrosine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Bausch Health Americas, Inc.
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
DiGeorge Syndrome, Complete Typical DiGeorge Anomaly
Thymus Transplantation in DiGeorge Syndrome #668
The study purpose is to determine whether cultured thymus tissue implantation (CTTI) is effective in treating typical complete DiGeorge syndrome.
- Trial name
- NCT00576407
- Testing
- Cultured Thymus Tissue for Implantation (CTTI)
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Marfan Syndrome
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities.
- Trial name
- NCT00429364
- Testing
- Losartan Potassium, Atenolol
- Where
- 26 sites in United States, Belgium and 1 more
- Volunteers
- 608 people
- Sponsor
- Carelon Research
Marfan Syndrome
Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS
Marfan syndrome (MFS) is an inherited disorder of connective tissue with morbidity and mortality from aortic dilatation and dissection.
- Trial name
- NCT01715207
- Testing
- Aliskiren, Atenolol
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- Samsung Medical Center
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
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
Tetralogy of Fallot, Pulmonary Insufficiency
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to…
- Trial name
- NCT05186415
- Testing
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nemours Children's Clinic
Structural Anomalies, Cardiac Anomalies
Clinical Utility of Prenatal Whole Exome Sequencing
The investigator aims to examine the clinical utility of WES, including assessment of a variety of health-related and reproductive outcomes in undiagnosed prenatal cases.
- Conditions
- Structural Anomalies, Cardiac Anomalies, Central Nervous System Anomalies, Thorax Anomalies
- Trial name
- PWES (NCT03482141)
- Testing
- Whole Exome Sequencing (WES)
- Where
- United States
- Volunteers
- 316 people
- Sponsor
- University of California, San Francisco
Turner Syndrome
Somatropin Treatment to Final Height in Turner Syndrome
A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final…
- Trial name
- GDCT (NCT00191113)
- Testing
- Somatropin, Ethinyl estradiol, Medroxyprogesterone acetate
- Where
- 14 sites in Canada
- Volunteers
- 154 people
- Sponsor
- Eli Lilly and Company
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Congenital Heart Disease
Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.
- Trial name
- PRISMACHD (NCT04738474)
- Testing
- Promoting Resilience in Stress Management (PRISM), Usual Care
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- University of Washington
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD)
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively.
- Conditions
- Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD)
- Trial name
- NCT00848393
- Testing
- Fentanyl (High Dose), Fentanyl (Low Dose), Fentanyl (Low Dose) + Dexmedetomidine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Nationwide Children's Hospital
Congenital Heart Disease
Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself.
- Trial name
- NCT00693498
- Testing
- Standard leukoreduced irradiated blood cell transfusion, Washed leukoreduced irradiated blood cell transfusions
- Volunteers
- 162 people
- Sponsor
- University of Rochester
Turner Syndrome
Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
The purpose of this research study is to learn about brain development in very young girls with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain development.
- Trial name
- NCT01367834
- Testing
- somatotropin
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Rebecca Knickmeyer Santelli, PhD
Congenital Heart Disease
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
- Trial name
- NCT00848250
- Testing
- Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Vanderbilt University Medical Center