Clinical trials: Defects
Congenital Heart Disease
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children
General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.
- Trial name
- NCT03144258
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
Hypoplastic Left Heart Syndrome
Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may have an impact on development.
- Trial name
- NIRS-ND (NCT00464100)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
CD55 - Cluster of Differentiation Antigen 55 Deficiency, Primary Intestinal Lymphangiectasis
Transcriptome and Metabolic Analyses of CHAPLE Disease
CHAPLE syndrome (complement hyperactivation, angiopathic thrombosis, protein losing enteropathy) is a newly discovered genetic disorder, which is caused by deleterious mutations in the CD55 gene.
- Conditions
- CD55 - Cluster of Differentiation Antigen 55 Deficiency, Primary Intestinal Lymphangiectasis, Protein-Losing Enteropathies, Complement Regulatory Factor Defect
- Trial name
- CHAPLEOMIC (NCT03950804)
- Testing
- Eculizumab Injection
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Marmara University
Congenital Heart Disease
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.
- Trial name
- NCT02378857
- Where
- Norway
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Congenital Heart Disease
Improving Motor Skill Development in Infants After Cardiac Surgery
The purpose of this study is to learn more about developmental behaviors and to examine changes in developmental progress related to motor activities among a group of infants who received open heart surgery within the first three…
- Trial name
- DAISY (NCT02700646)
- Testing
- Developmental recommendations, Standard care
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Michigan
Myelomeningocele Without Hydrocephalus, Sensory Defect
Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele
Myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. Functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor…
- Conditions
- Myelomeningocele Without Hydrocephalus, Sensory Defect, Motor Activity
- Trial name
- NCT04035863
- Testing
- Low level laser therapy
- Volunteers
- 30 people
- Sponsor
- University of Nove de Julho
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Single-ventricle
Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs.
- Trial name
- NCT04017494
- Testing
- Cardiac Magnetic Resonance Imaging, Blood draw for hematocrit and heart failure biomarkers, Cardiopulmonary exercise test
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Barbara Burkhardt
Congenital Heart Disease
Assessment of the Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease…
- Trial name
- NCT02064179
- Volunteers
- 75 people
- Sponsor
- University of Colorado, Denver
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
Upper Extremity Defects
Reconstruction of Hand and Upper Extremities Defects by Thin Random Pedicle Abdominal Flaps, Still a Valid Option in Developing Countries: A Cross Sectional Study
Traumatic defects of the soft tissues of the hand and upper extremities are common and may be challenging to the reconstructive surgeon.
- Trial name
- NCT04007497
- Where
- Jordan
- Volunteers
- 34 people
- Sponsor
- University of Jordan
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
Quality of Life, Abdominal Wall Defect
Health Related Quality of Life of Patients With Abdominal Wall Defects
Examination of the health-related quality of life of patients operated on due to congenital defects of the abdominal wall after birth with the questionnaires KINDL, SDQ and SF-36.
- Conditions
- Quality of Life, Abdominal Wall Defect, Gastroschisis, Omphalocele
- Trial name
- NCT03960320
- Testing
- questionnaire
- Volunteers
- 65 people
- Sponsor
- Universität des Saarlandes
Heart Defects, Congenital
Livet Skal Leves (A Life to Live)
The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications
- Trial name
- NCT03957512
- Testing
- Heart surgery
- Where
- Norway
- Volunteers
- 3,000 people
- Sponsor
- Oslo University Hospital
Cardiac Defect
Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate…
- Trial name
- NCT02751645
- Testing
- Acute Normovolemic hemodilution
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oregon Health and Science University
Congenital Heart Disease, Ischemia-reperfusion Injury
Pediatric Remote Ischemic Pre-conditioning Prior to Complex Cardiac Surgery
In 2012, infants having surgery for congenital heart disease have a high survival. The investigators are now focused on improving how sick these infants become after surgery (short term outcomes) and their later neurodevelopment…
- Trial name
- PREP (NCT01739088)
- Testing
- Remote ischemic pre-conditioning stimulus.
- Where
- Canada
- Volunteers
- 53 people
- Sponsor
- University of Alberta
Ventricular Septal Defect
A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD.
- Trial name
- NCT03941691
- Testing
- Fully Absorbable VSD Occlusion System, VSD Occluder
- Where
- 4 sites in China
- Volunteers
- 108 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Congenital Heart Defect, Cardiopulmonary Bypass
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of…
- Conditions
- Congenital Heart Defect, Cardiopulmonary Bypass, Inflammatory Response, Low Cardiac Output Syndrome
- Trial name
- ProCard (NCT03143348)
- Testing
- Single blood draw, Multiple blood draws
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Oklahoma
Heart Diseases
Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
This study intends to establish an automatic system for screening on children with congenital heart disease, the system include the auscultation of cardiac murmur and the test of oxygen saturation, the data was analyzed based on…
- Trial name
- NCT03929133
- Testing
- automatic screening machine on congenital heart disease
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine