Clinical trials: Cardiac Defect
Congenital Heart Defect
Use of ROTEM® in Pediatric Cardiac Surgical Patients
Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood loss during and after operation.
- Trial name
- PedsROTEM (NCT01212289)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Weill Medical College of Cornell University
Cardiac Surgery
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children
Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms.
- Trial name
- NCT02617602
- Testing
- Goal directed therapy, Control
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Ventricular Septal Defect, Complete Atrioventricular Canal
Optical Tissue Identification for Myocardial Architecture
The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
- Conditions
- Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
- Trial name
- OPTIMA (NCT04017975)
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Aditya Kaza
Cardiovascular Diseases, Heart Diseases
Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease
To identify genes involved in the pathogenesis of three types of congenital heart disease, atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal defects.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Heart Septal Defects, Ventricular
- Trial name
- NCT00005546
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ventricular Septal Defect
Cardiac Function After Transcatheter VSD Closure
With advances in interventional cardiac catheterization, ventricular septal defect (VSD) could be successfully treated via transcatheter device closure.
- Trial name
- NCT03127748
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- National Taiwan University Hospital
Congenital Heart Defect, Cerebrovascular Circulation
A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain…
- Trial name
- NCT03512613
- Testing
- c-FLOW 3310-P
- Where
- Israel
- Volunteers
- 55 people
- Sponsor
- Ornim Medical
Ventricular Septal Defect, Pulmonary Hypertension
The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension
Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief…
- Trial name
- NCT01313832
- Testing
- remote ischemic preconditioning (RIPC)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Ventricular Dysfunction, Pericardial Effusion
Focused Cardiac Ultrasound
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
- Conditions
- Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect
- Trial name
- NCT03887286
- Testing
- Philips EPIQ 7 ultrasound machine, Philips Lumify Broadband sector array transducer
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- University of Miami
Atrial Septal Defect
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each).
- Trial name
- NCT04096924
- Testing
- Guidewire for echo-guided interventions, Cook lunderquist guidewire
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Double Outlet Right Ventricle, Transposition of the Great Arteries
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management
Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images…
- Conditions
- Double Outlet Right Ventricle, Transposition of the Great Arteries, Truncus Arteriosus, Congenitally Corrected Transposition of the Great Arteries
- Trial name
- NCT04788082
- Testing
- 3D Printed Heart Model
- Where
- 3 sites in United States
- Sponsor
- Children's National Research Institute
Congenital Heart Disease, Congenital Heart Defect
Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery.
- Conditions
- Congenital Heart Disease, Congenital Heart Defect, Congenital Heart Malformations
- Trial name
- NCT05101746
- Testing
- Nitric Oxide (NO) 20 part per million (ppm), Standard of care cardiopulmonary bypass
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Vanderbilt University Medical Center
DiGeorge Syndrome, Shprintzen Syndrome
Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
OBJECTIVES: I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due to DiGeorge syndrome or velocardiofacial syndrome. II.
- Conditions
- DiGeorge Syndrome, Shprintzen Syndrome, Chromosome Abnormalities, Abnormalities, Multiple
- Trial name
- NCT00005102
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Center for Research Resources (NCRR)
Congenital Heart Defects, VSD
Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve…
- Trial name
- ABSORB-VSD (NCT07040579)
- Testing
- transcatheter closure of outlet VSDs with bioabsorbable occluders
- Where
- China
- Volunteers
- 50 people
- Sponsor
- First Affiliated Hospital of Guangxi Medical University
Neonatal Respiratory Failure, Congenital Heart Defect
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming.
- Trial name
- NCT03154112
- Testing
- Measurement of oxygen consumption and caloric expenditure
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Boston Children's Hospital
Transposition of the Great Arteries, Tetralogy of Fallot
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery…
- Conditions
- Transposition of the Great Arteries, Tetralogy of Fallot, Ventricular Septal Defect
- Trial name
- NCT01915277
- Testing
- Dexmedetomidine
- Where
- 4 sites in United States
- Volunteers
- 119 people
- Sponsor
- Carelon Research
Congenital Cardiac Defects
Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery
Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common.
- Trial name
- NCT02686255
- Testing
- complete blood count
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Heart Defect, Congenital, Executive Dysfunction
Executive Function Intervention for Children With Complex Congenital Heart Disease
Children with complex congenital heart disease (cCHD) nowadays survive thanks to medical advances into their teenage years and adulthood. However, many of them have difficulties with so-called executive functions.
- Trial name
- E-Fit Heart (NCT07692958)
- Testing
- E-Fit Intervention
- Where
- Switzerland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Bea Latal