Clinical trials: Coronary Bypass
Coronary Artery Disease
Rise Semi Compliant Balloon Study in Patient With CAD
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for…
- Trial name
- NCT04796038
- Testing
- Balloon dilatation
- Where
- 3 sites in Switzerland
- Volunteers
- 67 people
- Sponsor
- Biosensors Europe SA
Atrial Fibrillation
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.
- Trial name
- NCT00562432
- Testing
- Plexisyl-AF, No Treatment
- Where
- 3 sites in Germany
- Volunteers
- 32 people
- Sponsor
- LoneStar Heart, Inc.
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Acquired Antithrombin Deficiency
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating…
- Trial name
- NCT06096116
- Testing
- Human plasma derived antithrombin
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization
- Trial name
- NCT00157716
- Testing
- (MC-1) Pyridoxal-5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 900 people
- Sponsor
- Medicure
Cardiac Disease, Multiple Organ Dysfunction Syndrome
Hemoperfusion Efferon LPS During Cardiac Surgery Using Cardiopulmonary Bypass
More than 1 million people undergo cardiac surgery each year worldwide. Cardiac surgeries still in most cases require cardiopulmonary bypass, use of myocardial protection against aortic clamping and creation of cardioplegic…
- Trial name
- NCT06659289
- Testing
- Efferon LPS
- Where
- Russia
- Volunteers
- 14 people
- Sponsor
- Efferon JSC
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
Cardiac Surgical Procedures, Extracorporeal Circulation; Complications
Acute Kidney Injury After Cardiac Surgery
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1.
- Conditions
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- Trial name
- NCT04293744
- Testing
- Colloid priming solution for ECC circuit, Standard priming solution for ECC circuit
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- XVIVO Perfusion
Coronary Artery Bypass Surgery, Coronary Heart Disease
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00653042
- Testing
- Nesiritide
- Volunteers
- 305 people
- Sponsor
- Scios, Inc.
Left Ventricular Dysfunction
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5)…
- Trial name
- IMPACT (NCT05529654)
- Testing
- Impella 5.5 with SmartAssist
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first…
- Trial name
- NCT02239146
- Testing
- catridecacog
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
Heart Diseases, Lung Diseases
TandemHeart Experiences and MEthods (THEME Registry)
This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use…
- Trial name
- THEME (NCT02326402)
- Testing
- TandemHeart or LifeSPARC System
- Where
- 16 sites in United States
- Volunteers
- 365 people
- Sponsor
- CardiacAssist, Inc.
Atrial Fibrillation New Onset
Evaluation Of New Onset Postoperative Atrial Fibrillation
This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation…
- Trial name
- NCT01247974
- Testing
- CorMatrix ECM for Pericardial Closure
- Where
- 16 sites in United States
- Volunteers
- 439 people
- Sponsor
- Elutia Inc.
Coronary Artery Disease
Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG)
The goal of this study is to assess safety and efficacy of Humacyte's coronary tissue engineered vessel (CTEV) used as a bypass conduit in patients requiring multi vessel coronary artery bypass grafting (CABG).
- Trial name
- NCT07730528
- Testing
- Humacyte Coronary Tissue Engineered Vessel (CTEV)
- Volunteers
- 10 people
- Sponsor
- Humacyte, Inc.
Coronary Artery Disease
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either…
- Trial name
- SYNTAX (NCT00114972)
- Testing
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Where
- 106 sites in United States, Austria and 16 more
- Volunteers
- 1,800 people
- Sponsor
- Boston Scientific Corporation
Coronary Arteriosclerosis, Atrial Fibrillation
A(f)MAZE-CABG Study
Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG…
- Conditions
- Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery
- Trial name
- AFMAZE-CABG (NCT00735722)
- Testing
- HIFU AF Ablation
- Where
- 10 sites in Canada, Finland and 4 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Multi Vessel Coronary Artery Disease
Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)
A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the XABG technology in patients with multi-vessel atherosclerotic coronary artery disease, scheduled by the…
- Trial name
- XABG FIH (NCT04545112)
- Testing
- CABG
- Where
- 4 sites in Belgium, Lithuania and 1 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
Blood Loss, Surgical
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the…
- Trial name
- NCT00448864
- Testing
- Ecallantide
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Atrial Fibrillation, Atrial Flutter
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
- Trial name
- NCT00125320
- Testing
- RSD1235
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Inc