Clinical trials: Post-cardiac Surgery
AKI - Acute Kidney Injury, Cardiac Surgery Associated - Acute Kidney Injury
Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated…
- Trial name
- KIDNEY-II (NCT06811805)
- Testing
- RenalGuard Therapy, Standard of Care (SOC)
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 300 people
- Sponsor
- CardioRenal Systems, Inc.
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.
Post Cardiac Surgery Patients
Measurement of Cardiac Output and Blood Volumes Using Transonic Ultrasound Dilution Technology
Measurement of the amount of blood pumped by the heart (cardiac output) and blood volumes in sick patients is important for doctors to better treat these patients.
- Trial name
- NCT00756119
- Where
- Russia
- Volunteers
- 26 people
- Sponsor
- Transonic Systems Inc.
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
Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)
This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or…
- Trial name
- NCT03613831
- Testing
- patient who used Rhythmia system and Orion catheter
- Where
- China
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation, Atrial Flutter
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.
- Trial name
- NCT00125320
- Testing
- RSD1235
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Inc
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Vascular Disease
ArterX Safety and Efficacy Study for Cardiac Indications
The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide…
- Trial name
- NCT01957904
- Testing
- ArterX Surgical Sealant
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Tenaxis Medical, Inc.
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.
Renal Impairment After Cardiac Surgery, Renal Impairment
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively.
- Conditions
- Renal Impairment After Cardiac Surgery, Renal Impairment, Acute Kidney Injury
- Trial name
- GRADIENT (NCT07017933)
- Testing
- Renal assist device
- Where
- 7 sites in United States, Poland
- Volunteers
- 124 people
- Sponsor
- 3ive Labs
Rigid Plate Fixation, Median Sternotomy
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
- Trial name
- RACE XP (NCT05578651)
- Testing
- SternaLock XP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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
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
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
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.
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
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
Myocardial Infarction
the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.
This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.
- Trial name
- Danhong (NCT02158559)
- Testing
- Danhong Injection, Normal Saline
- Volunteers
- 180 people
- Sponsor
- Beijing Bozhiyin T&S Co., Ltd.
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