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Trial Shows Wearable Device Monitors Heart Rhythm Indicators

CardioWatch

CardioWatch LED and sensor (Corsano Health)

25 Aug. 2021. Results from a clinical trial show a device worn on the wrist can measure two key indicators of heart health as accurately as an electrocardiogram. The findings assessing the CardioWatch 287, a device made by Corsano Health in Bussum, The Netherlands, appear in the July-August issue of the Journal of Electrocardiology.

Corsano Health designed the CardioWatch 287 for continuous real-time monitoring of heart rhythms, particularly to detect arrhythmia or irregular heart beat, a common form of heart disease. Early detection of arrhythmia is important for effective care, since the condition causes few evident symptoms in many people. The gold-standard for detecting arrhythmia is the electrocardiogram or ECG that attaches 12 sensors to the torso, wired to a controller, to measure heart beats. An ECG, however, can only be administered in a doctor’s office or clinic by a trained clinician. As a result, ECGs are used intermittently, often after other symptoms appear, such as shortness of breath or lightheadedness.

The CardioWatch device uses a technology called photoplethysmography or PPG. Plethysmography measures changes in an organ’s volume, such as blood flow, and PPG extends that process with images for capturing the measurements. In this case, PPG measures blood volume changes in the tiny blood vessels under the skin. The CardioWatch is worn on the wrist and sends out light waves from an LED, with a sensor to measure blood volume changes, then calculated with algorithms. Data from the sensors are sent via Bluetooth to Preventicus Heartbeats, a third-party CE-cleared smartphone app for analysis and display. The app can also transmit data from the device to the cloud for continuous patient monitoring if needed.

ECG and PPG data recorded simultaneously

The clinical trial enrolled 180 participants with a history or symptoms of heart disease from outpatient cardiology clinics in The Netherlands, between July and November 2020. Participants had an average age of 60 and 56 percent were male. Those enrolled were asked to wear a CardioWatch 287 while clinicians gave them an ECG, providing simultaneous data from the two technologies. The study team from Cardiology Centers of the Netherlands, where participants were recruited, compared measures of heart rate and RR interval, time intervals between consecutive heart beats. No placebo was used or control group recruited.

The researchers recorded 7,914 ECG and 7,880 PPG heart beats from the 180 participants. Results show 95 percent of PPG readings matched ECG measures within 100 milliseconds, and 89 percent of PPG readings came within 50 milliseconds of ECG measures. In addition, both heart rate and RR interval measures from CardioWatch devices correlated strongly with ECG data, 0.99 and 0.89 respectively, where 1.0 is a perfect 1-to-1 match.

Corsano Health says it will use results of the study to bolster its case for medical device clearance from European regulatory agencies. “Corsano’s non-invasive ergonomic wearables,” says company CEO Peter Stas is a statement released through Cision, “deliver medically validated data with superior patient compliance. Additionally, the patient satisfaction survey conducted at the closure of the study cited convenience and ease to use of the CardioWatch 287 devices.”

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