Clinical trials: Congenital Heart Defect
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
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
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
Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
- Trial name
- NCT00626028
- Testing
- Nitric Oxide for inhalation, Oxygen, Nitric Oxide plus Oxygen
- Where
- 18 sites in United States, France and 3 more
- Volunteers
- 136 people
- Sponsor
- Mallinckrodt
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
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
Congenital Heart Disease
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Each year, there are over 400,000 cardiac surgical operations performed in the United States; of which 10,000 are performed on children.
- Trial name
- NCT00585013
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Washington University School of Medicine
Congenital Heart Defect
Erythropoietin and Pediatric Cardiac Surgery
Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may…
- Trial name
- EPO (NCT00451698)
- Testing
- acyanotic erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Medical College of Wisconsin
Atrial Septal Defect
Utilization of Confocal Microscopy During Cardiac Surgery
The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery.
- Trial name
- NCT03189134
- Testing
- Fluorescite, Cellvizio 100 Series System with Confocal Miniprobes
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aditya Kaza
Cirrhosis, Congenital Heart Disease
Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
The purpose of this study is to determine if the medication, sildenafil (also known as Revatio), can slow or stop the progression of liver disease in patients who previously had a Fontan operation.
- Trial name
- SiFALD (NCT03154476)
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Pediatric Congenital Heart Disease
Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease
The standard clinical cardiovascular MRI practice for children with CHD frequently involves the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast.
- Trial name
- NCT02752191
- Testing
- ferumoxytol, gadofosveset
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Paul Finn
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
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
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
Pulmonary Artery Hypertension, Congenital Heart Disease
Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers.
- Conditions
- Pulmonary Artery Hypertension, Congenital Heart Disease, Structural Heart Disease
- Trial name
- NCT03152773
- Testing
- MRI Heart guidewire catheterization
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypogammaglobulinemia, Congenital Heart Disease
Post-bypass Prophylactic IVIG in Infants and Neonates
The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact…
- Trial name
- NCT02043379
- Testing
- IVIG
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Alabama at Birmingham
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
Congenital Heart Disease
Acute Effects of Inhaled Treprostinil in Fontan Patients
In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular…
- Trial name
- NCT02769624
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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)