Validation PPG measured HR and RR compared with ECG

Title
Validation of Photoplethysmography Measured Heart Rate and RR-intervals with the Corsano CardioWatch 287 Module Compared with ECG 

Topic
To study the feasibility, efficacy and performance of the Corsano CardioWatch 287 module  with a photoplethysmographic sensor for measuring heart rate and RR-intervals

Number of Participants
100 presumably healthy people

Inclusion / Exclusion criteria

Inclusion criteria:
presumably healthy people
People ≥ 18 years old
non clinical environment

Exclusion criteria:
Bracelet cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
Study Design

Patients fulfilling the inclusion criteria will receive a wearable device (Corsano CardioWatch 287 provided by MMT) and a smartphone with the MMT-App. The smartwatch and the app on the smartphone are coupled. Continuous monitoring of heart rate and –rhythm will be conducted using photoplethysmography (PPG). Simultaneously, a 5 min resting ECG recording will be conducted. Data obtained with the Corsano CardioWatch 287 will be saved on the smartphone and will be downloaded by the physician at the end of the monitoring procedure. Data will then be analysed by trained analysts and supervising physicians at Cardiologie Centra Nederland. The PPG data from the Corsano CardioWatch 287 will be compared to a 5 minute, 12-lead resting ECG recording on the measurement of heart rate and RR-intervals.

Target Points
Main study parameters/endpoints: Percentage of heart rate and RR-intervals of the PPG sensor matching the resting ECG recording

Measurement procedures
Participants are requested to wear a smartwatch or bracelet for 5 minutes in addition to a resting ECG. Simultaneously, they will have the connected smartphone with them.

Study Centre
Cardiologie Centra Nederland, Amsterdam UMC, Location AMC (NL)

Start time, Duration
September 2020, 4 months

Interested in our Trial Programme?

Corsano Cardiowatch Bracelets enable continuous monitoring with multiple algorithms. Corsano is working closely with cardiologists, scientists, hospitals, patients, and research organisations.  Scientific research demonstrates the legitimacy of Cardiowatch 287 algorithms. 

We are currently performing pilots with selected clients. Contact us if you want to know more!

Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 19 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.  
 
The bracelet monitor offers flexibility to set data collection intervals by minute, by second or 25Hz, 32 Hz or 128 Hz. We measure Heart Rate, RR intervals, Breathing Rate, A-Fib detection, Skin Temperature, Activity and Sleep. SpO2, Core Body Temperature, ECG and Blood Pressure are in development.  
 
Clinical accuracy is paramount for us. In addition to third parties' algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started. 
 
Our end-to-end solution consists of light-weight and comfortable bracelets with a patient research portal. We have developed and produced over 200’000 devices. The Corsano platform has been optimized on connections, data buffers and battery life up to 15 days. We offer access to raw continuous high frequency data through API and cloud-to-cloud solutions. 
 

The founders of Corsano Health have over 100 years of experience in the Swiss Watch industry, with deep experience about ergonomic design and materials for wearables that are worn 24/7.