Clinical trials

The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals. The aim of this study is to further evaluate blood pressure measurements by the CardioWatch 287-2 in the intended remote setting across various demographic groups. Primary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and auscultatory blood pressure monitoring over a period of 31 days. Secondary objective: To assess the usability of the Corsano CardioWatch 287-2 from a patient perspective. Participants receiving multiple standardized paired auscultatory and Corsano CardioWatch blood pressure measurements over a 31-day period. The study group will include patients of different ages (above the age of 22 years), genders, and demographics.

Fever is a common symptom in many health conditions, but current methods to monitor body temperature (BT) are either invasive, costly, or not continuous. The Corsano CardioWatch 287-2, a wristband that tracks multiple vital signs, offers a new way to monitor BT by measuring skin temperature and heat flux on the wrist. It uses a machine learning algorithm to predict BT in real-time. The device has shown good results when compared to other non-invasive temperature measurements, like tympanic (ear) temperature, in stroke patients. However, it hasn't yet been compared to the gold standard of invasive rectal temperature monitoring in a clinical setting. This study aims to test the accuracy of the Corsano CardioWatch 287-2 in measuring body temperature against rectal temperature monitoring in a clinical environment.

This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter. To ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited: * Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring * Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation. * Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF. * Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care. The secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.

The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation. The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm. The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.