Clinical trials: Transplant, Heart
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Cardiovascular Disease, Coronary Artery Bypass
Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked.
- Trial name
- NCT00451256
- Testing
- AVI-5126
- Where
- Ukraine
- Volunteers
- 600 people
- Sponsor
- Sarepta Therapeutics, Inc.
Patients Successfully Completing the 12-month Treatment Period of the Core Study (de Novo Heart Recipients) Who Were Interested of Being Treated With EC-MPS
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Heart Transplant Recipients
This purpose of this extension study of patients being treated with EC-MPS is to assess the long term safety of this medication.
- Trial name
- NCT00238446
- Testing
- EC-MPS
- Sponsor
- Novartis Pharmaceuticals
Heart Disease
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken from the peer-reviewed…
- Trial name
- NCT01478061
- Testing
- Anastomosis (C-Port® )
- Where
- 7 sites in United States
- Volunteers
- 115 people
- Sponsor
- Cardica, Inc
Coronary Artery Bypass Surgery, Coronary Heart Disease
An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)
The purpose of this study is to assess whether nesiritide compared to placebo when given with standard of care therapies, helps preserve kidney function in heart failure (HF) patients undergoing heart bypass graft surgery that…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00530361
- Testing
- Nesiritide
- Sponsor
- Scios, Inc.
Coronary Artery Bypass Grafting (CABG) Surgery
A Study Testing the Elana Device for Multi-Artery Heart Bypass Surgery
The purpose of the trial is to evaluate the feasibility and safety of multiple Elana Anastomotic Systems to anastomose multiple arterial grafts during coronary artery bypass grafting (CABG).
- Trial name
- MULTI-CAB (NCT07005843)
- Testing
- The Elana Anastomotic System
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- AMT Medical BV
Chronic Total Occlusion of Coronary Artery
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional…
- Trial name
- NCT01978860
- Testing
- NovaCross, CTO
- Where
- Israel
- Volunteers
- 2 people
- Sponsor
- Chanan Schneider
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
Heart Failure, Transplant; Failure, Heart
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts…
- Trial name
- NCT05881278
- Testing
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
- Where
- 20 sites in United States
- Volunteers
- 141 people
- Sponsor
- XVIVO Perfusion
Heart Transplant
Enhancing Heart Allograft Function With the OCS Heart System Trial
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation.
- Trial name
- ENHANCE (NCT07145515)
- Testing
- OCS Heart, Static Cold Storage (SCS)
- Where
- 8 sites in United States
- Volunteers
- 655 people
- Sponsor
- TransMedics
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
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.
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
Heart Failure
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were…
- Trial name
- PROCEEDII (NCT00855712)
- Testing
- Organ Care System, Cold Cardioplegia Solution
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 128 people
- Sponsor
- TransMedics
Kidney Transplant
Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients
The purpose of this study is to confirm non-inferiority of delayed Prograf treatment to standard Prograf treatment in the incidence of delayed graft function (DGF) within 1 week between the 2 immunosuppressive (IS) treatment…
- Trial name
- NCT03644485
- Testing
- Tacrolimus immediate-release formulation, Tacrolimus prolonged-release formulation, Induction therapy
- Where
- 14 sites in China
- Volunteers
- 284 people
- Sponsor
- Astellas Pharma China, Inc.
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
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.
End-stage Renal Disease
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney…
- Trial name
- START-DCD (NCT03099122)
- Testing
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Sanofi
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
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.