Experimental clinical trial.
Echocardiography is currently the most important and most widely used tool in cardiology besides electrocardiography (ECG). It is commonly employed to detect cardiac wall motion dysfunction during and after open-heart surgery. Continuous monitoring of cardiac wall motion during surgery and in the postoperative recovery period can, e.g., be used to quickly identify the need for medical intervention and allows for very early detection of potentially serious complications such as ischemia and myocardial dysfunction with abnormal cardiac wall motion. A temporary pacemaker wire, also called a temporary myocardial electrode (TME), is used to pace the heart in case of postoperative arrythmias. Implementation of TMEs in open-heart surgery is part of the normal clinical routine.
In the study, a new TME has been developed (CS1), incorporating a motion detector, which enables continuous, direct measurements of cardiac wall motion. The key feature of the CS1 system is that the cardiac wall motion activity is displayed visually on a standard medical monitor and synchronized with the patient's ECG data. These data can easily be viewed by medical staff at the bedside to check if the patient's condition is satisfactory or whether medical intervention is needed. In the study, the CS1 system will be used in addition to the standard monitoring procedures that include ECG, blood pressures, and intermittent echocardiography. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare. The main investigation will be conducted at three sites, including our department as well as the Department of Cardiothoracic Surgery at Oslo University Hospital, Norway and the Berlin Heart Centre, Germany.
The aim of this study is to assess the safety and clinical performance of the CS1 system for the purposes and in the population for which it is intended.
This project is the result of a collaboration between by Cardiaccs AS, Department of Cardiothoracic and Vascular Surgery at Aarhus University Hospital, Department of Cardiothoracic Surgery at Oslo University Hospital, Berlin Heart Centre, and Osypka AG.
The study is funded by the EU grant under Horizon 2020 research and innovation programme (no. 831101).
Ongoing. Currently enrolling patients.