Clinical trials: Congenital Heart Defects
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
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 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
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 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
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates
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
22Q11 Deletion Syndrome
Mindfulness Program for Adolescents With 22q11DS
The goal of this study is to evaluate the effectiveness of the Aware Program, an online mindfulness education program, with adolescents with 22q11DS and their parents.
- Trial name
- NCT05849441
- Testing
- Aware Program
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Innovation Research & Training
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Additional Sizes
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA).
- Trial name
- ADO II AS (NCT03055858)
- Testing
- ADO II AS (PDA closure)
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Ventricular Septal Defects
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER…
- Trial name
- VPA (NCT00647387)
- Testing
- Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
- Where
- 51 sites in United States, Canada
- Volunteers
- 92 people
- Sponsor
- Abbott Medical Devices