Clinical trials: Patients Undergoing Cardiac Surgery
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
Coronary Artery Disease (CAD)
Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG
This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo.
- Trial name
- EXACT-CABG (NCT07118449)
- Testing
- XC001
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- XyloCor Therapeutics, Inc.
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Heart Disease
A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical…
- Trial name
- MiniMetrxics (NCT00500929)
- Testing
- CMI X-11S
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Cardiometabolics
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
Renal Insufficiency, Acute Kidney Injury
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing…
- Trial name
- BIPASS-AKI (NCT05990660)
- Testing
- JuxtaFlow System
- Where
- 3 sites in Poland, Serbia
- Volunteers
- 10 people
- Sponsor
- 3ive Labs
Cardiac Surgery, Coronary Artery Bypass Grafting
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Aortic Root or Ascending Aortic Aneurysm Repair Surgery
- Trial name
- NCT00903604
- Testing
- AP214
- Where
- 2 sites in Denmark
- Volunteers
- 42 people
- Sponsor
- Action Pharma A/S
General Anesthesia
Remimazolam Phase II Cardiac Anesthesia Study
This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general…
- Trial name
- NCT01937767
- Testing
- Remimazolam, Propofol, Sevoflurane
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Paion UK Ltd.
Post-Operative Atrial Fibrillation
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of…
- Trial name
- NCT03779841
- Testing
- AGN-151607
- Where
- 32 sites in United States, Austria and 7 more
- Volunteers
- 323 people
- Sponsor
- AbbVie
Aortic Valve Replacement
Homoeopathic Association in Aortic Valve Surgery
Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation…
- Trial name
- OMEO (NCT00774293)
- Testing
- Arnica and Bryonia
- Where
- France
- Volunteers
- 92 people
- Sponsor
- BOIRON
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Coronary Artery Disease
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
- Trial name
- NCT00364390
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Theregen, Inc.
Coronary Heart Disease, Graft Occlusion, Vascular
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG)…
- Trial name
- NCT01245634
- Testing
- RO4905417
- Where
- 38 sites in United States, Canada
- Volunteers
- 384 people
- Sponsor
- Hoffmann-La Roche
Non-anaemic Patients Undergoing Cardiac Surgery
A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
- Trial name
- CABG-01 (NCT01563367)
- Testing
- Iron isomaltoside 1000 (Monofer®), Natriumklorid 9 mg/ml, Fresenius Kabi
- Where
- Denmark
- Volunteers
- 74 people
- Sponsor
- Pharmacosmos A/S
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
Congestive Heart Failure
BMAC Enhanced Coronary Artery Bypass Grafting (CABG)
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
- Trial name
- NCT01061580
- Testing
- Harvest SmartPReP2 BMAC System
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Harvest Technologies
Cardio-pulmonary Bypass, Coronary Artery Bypass Graft
Effect of Pexelizumab on All-Cause Mortality and Myocardial Infarction in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardio-Pulmonary Bypass
During a heart bypass procedure, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, heart failure, or impairment of…
- Trial name
- NCT00048308
- Testing
- pexelizumab
- Where
- 186 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Alexion Pharmaceuticals, 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 Disease
Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. The study will evaluate subjects undergoing primary, elective, off-pump CABG surgery with median sternotomy.
- Trial name
- SNAP-CABG-OFF (NCT00808964)
- Testing
- NU172
- Volunteers
- 30 people
- Sponsor
- ARCA Biopharma, Inc.
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.