Clinical trials: Cardiac Surgical Procedure
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
Dilated Cardiomyopathy, Ischemic Cardiomyopathy
Optimized Biventricular Pacing Allograft Recipients
This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure.
- Trial name
- BiBET (NCT01290822)
- Testing
- BiVP, AAI Pacing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Henry M. Spotnitz
Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery, Inflammatory Reaction After Neonatal Cardiac Surgery
Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life.
- Trial name
- NCT02151877
- Testing
- Inhaled Nitric Oxide
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Wake Forest University Health Sciences
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Defects, Congenital, Cardiopulmonary Bypass
Nesiritide Use Following Cardiac Surgery in Infants
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
- Trial name
- NCT00281671
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Boston Children's Hospital
Postoperative Pain
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery…
- Trial name
- NCT04567407
- Testing
- Bilateral erector spinae blocks using ropivacaine
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
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
Acute Kidney Injury
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after…
- Trial name
- KIDPROAM (NCT01245595)
- Testing
- Aminophylline
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Stanford University
Pain
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used…
- Trial name
- NCT01094522
- Testing
- Methadone, Morphine
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Stanford University
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
Coronary Artery Bypass, Myocardial Ischemia
Glutamate for Metabolic Intervention in Coronary Surgery
The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart…
- Conditions
- Coronary Artery Bypass, Myocardial Ischemia, Myocardial Infarction, Coronary Artery Disease
- Trial name
- GLUTAMICS (NCT00489827)
- Testing
- Intravenous infusion of saline, Intravenous glutamate infusion
- Where
- 3 sites in Sweden
- Volunteers
- 865 people
- Sponsor
- University Hospital, Linkoeping
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
Cardiac Disease, Cardiac Surgery
Platelet Transfusion During Neonatal Open Heart Surgery
Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early…
- Conditions
- Cardiac Disease, Cardiac Surgery, Cardiopulmonary Bypass, Platelet Transfusion
- Trial name
- CPB (NCT03045068)
- Testing
- Platelet Transfusion, FFP and Cryoprecipitate, PRBC and cell saver Transfusion
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- The University of Texas Health Science Center, Houston
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, 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
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Pain
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares.
- Trial name
- NCT02512861
- Testing
- Bupivacaine
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota