Clinical trials: Surgery, Cardiac
Mitral Valve Insufficiency
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when…
- Trial name
- ReChord (NCT02803957)
- Testing
- NeoChord DS1000, Surgical Mitral Valve Repair
- Where
- 14 sites in United States
- Volunteers
- 585 people
- Sponsor
- NeoChord
AKI - Acute Kidney Injury, Cardiac Surgery
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device.
- Conditions
- AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability
- Trial name
- NCT07022314
- Testing
- FIZE kUO®
- Where
- Israel
- Volunteers
- 45 people
- Sponsor
- FIZE Medical ltd
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
Hemorrhage
Experiences With Automated Surgical Drainage in Cardiac Surgery
The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over the current standard of care…
- Trial name
- NCT03860363
- Testing
- Blood drainage post cardiac surgery
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Centese, Inc.
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM
Patients with coronary artery disease requiring PCI treatment were enrolled in the study. All patients underwent PCI with the robotic R-OneTM System (R-One Vascular Robotics, Cathbot).
- Trial name
- tele-PCI (NCT07132255)
- Testing
- R-One assisted tele-PCI, R-One assisted on-site PCI
- Where
- 5 sites in China
- Volunteers
- 60 people
- Sponsor
- Cathbot (Shanghai) Robot Co., Ltd
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Coronary Artery Bypass Surgery
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during…
- Trial name
- NCT00858936
- Testing
- IK-1001, Normal Saline
- Where
- 8 sites in Australia, Canada
- Volunteers
- 6 people
- Sponsor
- Mallinckrodt
Coronary Artery Disease
Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.
- Trial name
- NCT02072239
- Testing
- Angioshield
- Where
- Poland
- Volunteers
- 13 people
- Sponsor
- Neograft Technologies, Incorporated
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
Critical Illness
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients.
- Trial name
- Aldea_02 (NCT00882427)
- Testing
- enhanced model predictive control algorithm (eMPC)
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- B. Braun Melsungen AG
Stroke
Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing…
- Trial name
- NCT01737749
- Testing
- Neurokeeper stroke detector
- Where
- Israel
- Sponsor
- Neurokeeper Technologies
Non-cardiac Surgical, Intensive Care Unit (ICU)
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
- Trial name
- HIPULSE (NCT06895590)
- Testing
- Philips Advanced Monitoring Cuff (i.e. AMC)
- Where
- 4 sites in United States, Germany
- Volunteers
- 205 people
- Sponsor
- Philips Clinical & Medical Affairs Global