Clinical trials: Non Cardiac Surgery
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Cardiac Surgery, Cardiopulmonary Bypass
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
- Trial name
- COLCHIRCARD (NCT02584868)
- Testing
- Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution, Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
- Where
- Belgium
- Volunteers
- 88 people
- Sponsor
- Queen Fabiola Children's University Hospital
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Coronary Artery Disease
The MASS COMM Post-Randomization Phase Cohort Study
The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than…
- Trial name
- NCT02072421
- Testing
- PCI
- Where
- 10 sites in United States
- Volunteers
- 2,879 people
- Sponsor
- Baim Institute for Clinical Research
Atrial Fibrillation, Atrial Flutter
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)
The prevention of perioperative atrial fibrillation (AF) and myocardial injury after non-cardiac surgery (MINS) has the potential to reduce mortality, stroke, and hospital stays in patients undergoing major thoracic surgery.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Myocardial Injury After Non-Cardiac Surgery
- Trial name
- COP-AF (NCT03310125)
- Testing
- Active Colchicine
- Where
- 46 sites in United States, Austria and 9 more
- Volunteers
- 3,209 people
- Sponsor
- Population Health Research Institute
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
Coronary Artery Disease, Myocardial Ischemia
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01681095
- Testing
- Custodiol HTK, Cold Blood Cardioplegia
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Marc Sakwa, MD
Inflammation, Perioperative Morbidity
The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery.
- Trial name
- NCT00995501
- Testing
- Dexamethasone Sodium Sulfate, Insulin, anesthesia management
- Where
- United States
- Volunteers
- 381 people
- Sponsor
- d sessler
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
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
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.
Perioperative Care, Surgery--Complications
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care.
- Conditions
- Perioperative Care, Surgery--Complications, Hypothermia; Anesthesia, Myocardial Injury
- Trial name
- PROTECT (NCT03111875)
- Testing
- aggressive warming, routine thermal management
- Where
- 11 sites in United States, China
- Volunteers
- 5,056 people
- Sponsor
- The Cleveland Clinic
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Valvular Heart Surgery
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest…
- Trial name
- NCT04244981
- Testing
- Prothrombin Complex Concentrate, Human, Fresh Frozen Plasma
- Where
- 2 sites in China
- Volunteers
- 476 people
- Sponsor
- SHI Jia
Myocardial Injury
Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery
The purpose of this pilot study is to establish the rate of cardiovascular events in patients with elevated troponins levels after major, non-cardiac surgery and to evaluate the efficacy and safety of FDA approved study drug…
- Trial name
- INTREPID (NCT02291419)
- Testing
- ticagrelor, aspirin
- Where
- 24 sites in United States
- Volunteers
- 6 people
- Sponsor
- The Cleveland Clinic
Acute Kidney Injury (AKI)
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
- Trial name
- NCT04829916
- Testing
- RMC-035
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Guard Therapeutics AB
Hyperglycemia
Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
- Trial name
- NCT02741687
- Testing
- Sitagliptin, Supplemental insulin (insulin lispro), Supplemental insulin (insulin aspart)
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Emory University