Clinical trials: Cardiac Surgical Patients
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
Pain
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery
The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery
- Trial name
- NCT00636064
- Testing
- Parecoxib Sodium/Valdecoxib
- Where
- 206 sites in United States, Argentina and 25 more
- Volunteers
- 1,671 people
- Sponsor
- Pfizer
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG)…
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
- Trial name
- NCT00402506
- Testing
- (MC-1) Pyridoxal 5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Medicure
Post-cardiac Surgery, Intensive Care Unit Patients
Evaluation and Calibration of a Novel Non-invasive Wearable Device for Monitoring Vital Signs
The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS…
- Trial name
- NCT04081987
- Testing
- non-invasive monitoring
- Where
- 2 sites in Israel
- Volunteers
- 50 people
- Sponsor
- BiPS Medical
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.
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Surgery
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.
- Trial name
- RECOVER I (NCT00596726)
- Testing
- IMPELLA LP/LD 5.0
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abiomed Inc.
Aortic Valve Disease
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A prospective, multicenter, nonrandomized, single-arm, clinical study.
- Trial name
- NCT03025971
- Testing
- J-Valve Transcatheter Aortic valve replacement
- Where
- 3 sites in China
- Volunteers
- 107 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Open Heart Surgery
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.
- Trial name
- NCT06168799
- Testing
- Ilofotase alfa
- Where
- 13 sites in Belgium, Germany and 3 more
- Volunteers
- 271 people
- Sponsor
- AM-Pharma
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Critical Illness
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care.
- Trial name
- DELIOS 02 (NCT01233271)
- Testing
- Space TGC
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- B. Braun Melsungen AG
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Not Anemic and Who Will be Undergoing Orthopedic or Heart and Blood Vessel Surgery
The purpose of this study is to determine whether epoetin alfa will enable self-donation of at least 4 units of blood during the 2-week period before surgery (which is a shorter period of time than the conventional 3-week blood…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270075
- Testing
- epoetin alfa
- Volunteers
- 80 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ventilator Induced Diaphragm Dysfunction
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT04899856)
- Testing
- TransAeris
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Patient With Clinically Indicated Invasive Monitoring
ClearSight System CHN Study
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary…
- Trial name
- NCT03807622
- Testing
- EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
- Where
- 3 sites in China
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation
SOLAR & ATRILAZE Atrial Fibrillation Trial
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
- Trial name
- SAAF-T (NCT00734058)
- Testing
- Laser MAZE by Ablation of Cardiac Tissue
- Volunteers
- 90 people
- Sponsor
- EndoPhotonix, Inc.
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Cardiac Surgery
Efficacy and Safety of Sodium Heparin in Patients (Cristália)
The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require…
- Trial name
- NCT00894998
- Testing
- heparin sodium - Cristália, Heparin sodium APP
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil
Heart Failure
AZD8601 Study in CABG Patients
This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study in patients with moderately impaired systolic function undergoing CABG surgery.
- Trial name
- NCT03370887
- Testing
- AZD8601
- Where
- 10 sites in United States, Finland and 3 more
- Volunteers
- 11 people
- Sponsor
- AstraZeneca
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