Clinical trials: Surgery, Cardiac
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
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
Heart Defects, Congenital
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
The staged surgical pathway to treat children with single ventricle heart defects culminates with the Fontan operation. In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to…
- Trial name
- NCT00543309
- Testing
- nesiritide, milrinone
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- John M Costello
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
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
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
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
Mitral Valve (MV) Regurgitation
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR).
- Trial name
- ACCESS-EU (NCT01288976)
- Testing
- MitraClip, Medical Management, Mitral Valve Surgery
- Where
- Germany
- Volunteers
- 721 people
- Sponsor
- Abbott Medical Devices
Mitral Valve or Aortic Valve Replacement
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace…
- Trial name
- NCT02381678
- Testing
- Perimount 2900/6900 Heart Valve
- Where
- China
- Volunteers
- 225 people
- Sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
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