Clinical trials: Post-cardiac Surgery
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Median Sternotomy
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk…
- Trial name
- FIXTER-2 (NCT05953259)
- Testing
- Combination of STERN FIX and wires, Wires
- Where
- 5 sites in Germany, Spain
- Volunteers
- 90 people
- Sponsor
- NEOS Surgery
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, 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
Cardiac Defect, Cardiac Anomaly
Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)
The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular…
- Conditions
- Cardiac Defect, Cardiac Anomaly, Pericardial Defect
- Trial name
- NCT06088680
- Testing
- Glycar Pericardial Patch
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Cardiac Disease, Post Surgery Patients
Comparison of Cardiac Output Measured by Ultrasound Dilution Method and Pulmonary Artery Thermodilution Technique
Cardiac output (CO) is an important hemodynamic variable in the management of critically ill patients. The pulmonary artery catheter (PAC) requires invasive techniques with potential complications and there is increasing interest…
- Trial name
- NCT01616017
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Transonic Systems Inc.
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI).
- Trial name
- HICOSIRS (NCT01579396)
- Testing
- septeX, standard therapy
- Where
- Germany
- Sponsor
- Vantive Health LLC
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.
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
Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
This is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and cardiac valve replacement procedures that require…
- Trial name
- FCAD02 (NCT00838383)
- Testing
- sitaxsentan (Thelin)
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Pfizer
Hemodynamic Monitoring, ICU
Automated Inferior Vena Cava Collapsibility Index Fluid Responsiveness in Ventilated Patients After Cardiac Surgery.
Echocardiographic measurement of inferior vena cava (IVC) collapsibility index (CI) with automated software analyses has been introduced.
- Conditions
- Hemodynamic Monitoring, ICU, Cardiac Surgery
- Trial name
- NCT05283590
- Testing
- Automated echocardiographic inferior vena cava measurement
- Where
- Qatar
- Volunteers
- 50 people
- Sponsor
- Hamad Medical Corporation
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.
Post Operative Patient, Patients Requiring PCA
Evaluation of EverOn™ System in Medical / Surgical Ward
The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.
- Conditions
- Post Operative Patient, Patients Requiring PCA, Respiratory Patients, Patients in Risk of Fall
- Trial name
- NCT00640718
- Where
- United States
- Sponsor
- EarlySense Ltd.
Myocardial Ischemia, Coronary Artery Disease
Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) Surgery
In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.
- Trial name
- PERFECT (NCT00950274)
- Testing
- CD133+ autologous bone marrow stem cell
- Where
- 6 sites in Germany
- Volunteers
- 81 people
- Sponsor
- Miltenyi Biotec B.V. & Co. KG
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Pulmonary Hypertension
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary…
- Trial name
- NCT05699486
- Testing
- PDNO
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Attgeno AB
Atrial Appendage
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
- Trial name
- CLAARITY (NCT07742839)
- Testing
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Volunteers
- 168 people
- Sponsor
- Edwards Lifesciences
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
Heart Disease, Cardiac Surgery
Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart Surgery
This prospective, single-arm study aims to evaluate the effectiveness of Phase I cardiac rehabilitation based on remote electrocardiographic (ECG) monitoring in patients undergoing heart surgery.
- Conditions
- Heart Disease, Cardiac Surgery, Cardiac Rehabilitation
- Trial name
- NCT07736066
- Testing
- MEMO Patch, Phase I Cardiac Rehabilitation Program
- Where
- South Korea
- Volunteers
- 22 people
- Sponsor
- HUINNO Co., Ltd