Clinical trials: Cardiac Surgical Procedures
Congenital Heart Disease in Children
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe…
- Trial name
- NCT05647161
- Testing
- BAX602, No Intervention
- Where
- 6 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Baxter Healthcare Corporation
Dilated Cardiomyopathy
Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery
This is a pilot study to evaluate the feasibility and safety of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular restoration in patients with dilated…
- Trial name
- NCT00847964
- Testing
- Algisyl-LVR
- Where
- 3 sites in Germany, Poland
- Volunteers
- 11 people
- Sponsor
- LoneStar Heart, Inc.
Cardiac Surgery, Coronary Artery Bypass Grafting
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Kidney Injury
- Trial name
- NCT00628264
- Testing
- AP214
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Action Pharma A/S
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Post Cardiac Surgery, Sternal Closure
TORQ Clinical Study
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
- Trial name
- TORQClin (NCT01647178)
- Testing
- TORQ assisted sternal closure, Conventional closure
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Kardium Inc.
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Heart Diseases, Cardiac Surgery
Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System
This study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery.
- Conditions
- Heart Diseases, Cardiac Surgery, Cardiac Arrhythmias
- Trial name
- NCT07725445
- Testing
- MEMO Patch
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- HUINNO Co., Ltd
Sternum Closure
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery.
- Trial name
- STEADY (NCT06065800)
- Testing
- STEELEX® Sternum Set
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
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.
Autonomic Nervous System Imbalance, Stress
Burnout Among Cardiac Anaesthesiology and Cardiac Surgery Residents
To evaluate autonomic nervous system disturbances with respect to Ansiscope in cardiac anaesthesia residents in 24hrs shift.
- Trial name
- NCT07835009
- Testing
- ANSiScope
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- DyAnsys, Inc.
Acute Kidney Injury, Cardiac Surgery
LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria: 1.
- Trial name
- NCT05879432
- Testing
- LSALT Peptide
- Where
- 9 sites in Canada, Turkey (Türkiye)
- Volunteers
- 240 people
- Sponsor
- Arch Biopartners Inc.
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
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.
Percutaneous Coronary Intervention
A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI).
- Trial name
- NCT06502938
- Testing
- Pan-vascular interventional robotic system, Traditional artificial percutaneous coronary intervention
- Where
- 5 sites in China
- Volunteers
- 159 people
- Sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer