Clinical trials: Post Cardiac Surgery
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Post-discharge Outcomes
Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery
This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.
- Trial name
- NCT07009340
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Renibus Therapeutics, Inc.
Anesthesia
Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular…
- Trial name
- NCT02523859
- Testing
- Propofol, Remimazolam
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Paion UK Ltd.
Post Cardiac Surgery
Measure Cardiac Output Using Ultrasound Dilution in Mechanically Ventilated Children
The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients.
- Trial name
- NCT01662141
- Where
- Sweden
- Volunteers
- 33 people
- Sponsor
- Transonic Systems Inc.
Left Ventricular Dysfunction
IMPACT EU Post-Market Clinical Follow-Up Study
The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.
- Trial name
- NCT05756751
- Testing
- Device: Impella 5.5 with SmartAssist
- Where
- 13 sites in Czechia, Germany
- Volunteers
- 123 people
- Sponsor
- Abiomed Inc.
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Delirium
A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Heart Surgery
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG)…
- Trial name
- NCT00464763
- Testing
- Dexmedetomidine
- Where
- 11 sites in United States
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Aortic Valve Stenosis
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- NCT02209298
- Testing
- CoreValve Transcatheter Valve
- Where
- 25 sites in France, Germany and 2 more
- Volunteers
- 202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
SGLT2 inhibitors are oral anti-diabetic medications that were found to improve cardiorenal outcomes in patients with type 2 diabetes mellitus (DM), chronic heart failure with reduced and preserved ejection fraction, and chronic…
- Trial name
- NCT06251453
- Testing
- SGLT2 inhibitor
- Where
- 2 sites in Qatar
- Volunteers
- 3,280 people
- Sponsor
- Hamad Medical Corporation
Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy
Comparison of Central Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The intent of this study is to validate the venous blood oxygenation measurements of the Mespere VA Oximeter compared to the saturations measured by venous blood sampling through an inserted central vein catheter, which is…
- Conditions
- Sepsis, Post Cardiac Surgery Low Output Syndrome Requiring Inotropic/Vasopressor Therapy, Cardiogenic Shock Post Myocardial Infarction, Hypoxemic Respiratory Failure.
- Trial name
- NCT01788956
- Testing
- Mespere Venous Oximeter, Co-Oximeter
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Mespere Lifesciences Inc.
Valve Heart Disease
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial…
- Trial name
- NCT03347851
- Testing
- MRI, Transthoracic echocardiography exam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CryoLife, Inc.
Cardiac Disease, Myocardial Dysfunction
Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography.
- Trial name
- NCT04886934
- Testing
- CS1 System
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Cardiaccs AS
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.
Cardiovascular Diseases
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
- Trial name
- SYMBIOSIS (NCT04241328)
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Medtronic Cardiac Surgery
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
Coronary Artery Disease
GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT03635606
- Where
- 3 sites in United States
- Volunteers
- 370 people
- Sponsor
- Sapere Bio
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
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
Right Ventricular Outflow Tract Stenosis
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.
- Trial name
- NCT02071654
- Testing
- Venus P-valve transcatheter implantation
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Venus MedTech (HangZhou) Inc.