Clinical trials: Congenital Heart Defect
Atrial Septal Defect, Ventricular Septal Defect
Regional Anesthesia Following Pediatric Cardiac Surgery
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Pain, Procedural
- Trial name
- NCT05688670
- Testing
- Regional Anesthesia, Wound infiltration, Ropivacaine 0.2% Injectable Solution
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Duke University
Heart Defects, Congenital, Hyperglycemia
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk…
- Trial name
- SPECS (NCT00443599)
- Testing
- Insulin, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 989 people
- Sponsor
- Boston Children's Hospital
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Heart Defect, Congenital
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract…
- Trial name
- Xplore2 (NCT03022708)
- Testing
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Where
- 10 sites in United States, Bulgaria and 2 more
- Volunteers
- 6 people
- Sponsor
- Xeltis
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
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 Defect
The Effects of Inhaled Nitric Oxide After Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance.
- Trial name
- NCT00945529
- Testing
- inhaled nitric oxide (iNO)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ellen Spurrier
Dexmedetomidine, Congenital Heart Disease
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease…
- Trial name
- NCT03417999
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Children's Hospital of Philadelphia
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
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
Congenital Heart Disease
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
- Trial name
- RUBATO (NCT03153137)
- Testing
- Macitentan 10 mg
- Where
- 32 sites in United States, Australia and 10 more
- Volunteers
- 142 people
- Sponsor
- Actelion
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
Congenital Heart Disease
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.
- Trial name
- NCT00868101
- Testing
- Remote ischemic preconditioning
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- University of Sao Paulo
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
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 Disease in Children, Inflammatory Response
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass.
- Trial name
- STRESS (NCT03229538)
- Testing
- Methylprednisolone, Isotonic saline
- Where
- 23 sites in United States
- Volunteers
- 1,263 people
- Sponsor
- Kevin Hill
Congenital Heart Defects
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children.
- Trial name
- NCT00397514
- Testing
- Congenital Heart Surgery Patients
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of British Columbia
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Congenital Heart Disease, Disorder of Fetus or Newborn
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition…
- Trial name
- NCT01579513
- Testing
- Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medical University of South Carolina
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