Clinical trials: Surgery (Cardiac)
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
Kidney Injury
Prevention of Acute Kidney Injury in Cardiac Surgery Patients
Acute kidney injury (AKI) has no uniform criteria, but is commonly defined as an increase in serum creatinine concentration by at least 25% from baseline.
- Trial name
- NCT00921518
- Testing
- Sodium Bicarbonate
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Community Medical Center, Scranton, PA
Diabetes Mellitus
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
- Trial name
- NCT00717288
- Testing
- Detemir
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Ohio State University
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
Cardiopulmonary Bypass Surgery
HPI (Hypotension Prediction Index) Care Trial
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients…
- Trial name
- NCT05083403
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Edwards Lifesciences
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Cardiac Disease
Lidocaine as an Endotracheal Tube (ETT) Cuff Media
Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing tube cuff which is gently inflated to hold in place the trachea (airway) during surgery.
- Trial name
- NCT03343080
- Testing
- 1.8% lidocaine plus 0.76% sodium bicarbonate, Air
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation, Esophagectomy
Prevention of Atrial Fibrillation Following Esophagectomy
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery.
- Trial name
- NCT00420017
- Testing
- Amiodarone, Control
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Indiana University
Bleeding
Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery
The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery, with the hypothesis that TA is more…
- Trial name
- NCT02655653
- Testing
- Epsilon-aminocaproic acid administered, Tranexamic Acid administered
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis
Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)
The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to…
- Trial name
- CASCADE (NCT00228423)
- Testing
- Clopidogrel 75 mg daily, water pill daily
- Where
- Canada
- Volunteers
- 113 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Aortic Valve Disorder
CO2 Versus Lund De-airing Technique in Heart Surgery
To evaluate which of the two de-airing methods (CO2 insufflation vs. Lund de-airing technique) can shorten the left heart de-airing time and prevent or minimize cerebral air emboli during open surgery involving exposure of the…
- Trial name
- NCT00934596
- Testing
- Lund de-airing technique, carbon-dioxide insufflation
- Volunteers
- 20 people
- Sponsor
- Lund University
Disorder of Vitamin C, Atrial Fibrillation
High Dose Vitamin C in Cardiac Surgery Patients
Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the…
- Conditions
- Disorder of Vitamin C, Atrial Fibrillation, Complications Due to Coronary Artery Bypass Graft, Heart Valve Disease
- Trial name
- NCT02762331
- Testing
- Ascorbic Acid
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Virginia Commonwealth University
Coronary Artery Disease
The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
To investigate the safety of nitrous oxide (N2O) anaesthesia in patients with risk factors for coronary artery disease undergoing major surgery.
- Trial name
- NCT00430989
- Testing
- Nitrous Oxide, No Nitrous Oxide
- Where
- Australia
- Volunteers
- 7,112 people
- Sponsor
- Bayside Health
Cardiac Surgery, Cardiopulmonary Bypass
Voluven® in Paediatric Patients
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
- Trial name
- NCT00860405
- Testing
- HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 61 people
- Sponsor
- Fresenius Kabi
Cardiovascular Diseases, Coronary Disease
Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease
This study will compare medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease (CAD).
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Failure, Congestive, Heart Diseases
- Trial name
- STICH (NCT00023595)
- Testing
- CABG surgery plus MED, Active Medication Alone, CABG plus MED and SVR
- Where
- United States
- Volunteers
- 2,136 people
- Sponsor
- Duke University
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
Vitamin D Deficiency, Thoracic Surgery
Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery.
- Conditions
- Vitamin D Deficiency, Thoracic Surgery, Pediatric Disorders, Heart Defects, Congenital
- Trial name
- HICCUPS 2 (NCT01838447)
- Testing
- Cholecalciferol
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- Children's Hospital of Eastern Ontario
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease
EXCEL Clinical Trial
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with…
- Conditions
- Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205776)
- Testing
- Percutaneous Coronary Intervention, CABG
- Where
- United States
- Volunteers
- 1,905 people
- Sponsor
- Abbott Medical Devices