Clinical trials: Cardiac Surgery
Coronary Disease, Coronary Stenosis
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in…
- Trial name
- FAME 3 (NCT02100722)
- Testing
- FFR guided PCI, CABG, Resolute Integrity Stent
- Where
- 46 sites in United States, Australia and 14 more
- Volunteers
- 1,500 people
- Sponsor
- Stanford University
Acute Kidney Injury
Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing…
- Trial name
- MGHK23 (NCT02836899)
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Massachusetts General Hospital
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Bleeding
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac…
- Trial name
- NCT01530399
- Testing
- MDCO 1, MDCO 2, MDCO 3
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 44 people
- Sponsor
- The Medicines Company
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Heart Failure, Ventricular Dysfunction
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery.
- Trial name
- NCT01605019
- Testing
- CoSeal, BioGlue® Surgical Adhesive
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- The Methodist Hospital Research Institute
Coronary Artery Bypass Graft Surgery, Presence of Heparin/Platelet Factor 4 Antibody
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery.
- Trial name
- NCT01246011
- Testing
- Argatroban and warfarin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Massachusetts General Hospital
Acute Kidney Injury, Congenital Heart Disease
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
The proposed study will investigate the effect of sodium bicarbonate on the prevention of acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass.
- Trial name
- NCT02046135
- Testing
- Sodium Bicarbonate, Sodium Chloride
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Northwell Health
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
Aortic Regurgitation
HAART Model 300 Annuloplasty Ring
This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D…
- Trial name
- NCT01400841
- Testing
- HAART 300 Annuloplasty Device
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 18 people
- Sponsor
- Biostable Science & Engineering
Fluid Therapy
The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor.
- Trial name
- NCT02841046
- Testing
- cardiac index, Stroke Volume Variation
- Volunteers
- 50 people
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
Non-cardiac Surgery
Prevention of Opioid-Induced Hypoxemia
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
- Trial name
- NCT04453722
- Testing
- Oxalert Monitor Mode, Oxalert Normal mode
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- The Cleveland Clinic
Stress Hyperglycemia
Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.
- Trial name
- NCT03743025
- Testing
- Dulaglutide Injection, Saline Injection
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Emory University
Coronary Artery Bypass Graft, Non-cardiac Thoracic Surgery
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients.
- Conditions
- Coronary Artery Bypass Graft, Non-cardiac Thoracic Surgery, Frailty
- Trial name
- NCT03299101
- Testing
- Prehabilitation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- VA Office of Research and Development
Dissection of Thoracic Aorta
Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion…
- Trial name
- NCT01369732
- Testing
- recombinant human erythropoietin, saline
- Where
- South Korea
- Volunteers
- 66 people
- Sponsor
- Yonsei University
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Deep Vein Thrombosis, Coronary Artery Bypass Surgery
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis
This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated and redo isolated) versus…
- Conditions
- Deep Vein Thrombosis, Coronary Artery Bypass Surgery, Venous Thromboembolism
- Trial name
- NCT00789399
- Testing
- Fondaparinux
- Volunteers
- 78 people
- Sponsor
- Prairie Education and Research Cooperative
Aortic Valve Disease, Mitral Valve Disease
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.
- Trial name
- NCT05076604
- Testing
- Cardioplegia Solution, Microplegic Solution No. 1
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Washington University School of Medicine
Surgery, Cardiac
Contract-Relax (CR) Technique in the Management of Diaphragmatic Paresis After Cardiac Surgery
Postoperative respiratory complications are common complications of patients after cardiac surgery and increase morbidity and mortality and hospital length of stay.
- Trial name
- COREDIA (NCT05068219)
- Testing
- Usual physical therapy, Contract-Relax technique
- Where
- France
- Volunteers
- 27 people
- Sponsor
- CMC Ambroise Paré