Multi-Centre based study Recognition of Atrial Fibrillation with the Corsano CardioWatch 287-2 System

Rationale
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting across various demographic groups is lacking.

Study Design
Multi-center, single-arm, diagnostic accuracy study across four patient groups (A–D), comparing continuous CardioWatch monitoring (PPG + single-lead ECG spot-checks) against ECG Holter or in-clinic 12-lead ECG as reference.

Primary objective
To compare episodes of atrial fibrillation across 30-second intervals detected by the Corsano CardioWatch 287-2 with episodes detected by conventional Holter monitoring (24–48 hours) or short in-clinic 12-lead ECG, based on PPV, NPV, sensitivity and specificity.

Secondary objective
To compare the number of AF episodes >6 minutes, 1, 6, and 12 hours duration detected by the CardioWatch versus Holter, and to assess primary outcomes across demographic subgroups, patient activity, and signal quality index.

Study population
Group A: patients receiving a standard-of-care ECG Holter. Group B: patients with known (paroxysmal) AF attending routine follow-up. Group C: patients with (paroxysmal) AF recruited via a patient organisation. Group D: patients receiving a standard-of-care in-clinic 12-lead ECG.

Main study parameters/endpoints
AF/atrial flutter episodes among 30-second intervals detected on (1) Holter/12-lead ECG, (2) CardioWatch PPG signal, and (3) CardioWatch single-lead ECG spot-checks.

Secondary study parameters/endpoints
AF episodes >6 min/1/6/12 hours detected by Holter vs. CardioWatch PPG; compliance with ECG alerts; outcomes by demographic subgroup (sex, skin colour, BMI, ethnicity), patient activity, and signal quality.

Number of Participants
350 total (approx. 75 in Group A, 75 in Group B, 50 in Group C, 150 in Group D), recruited across Dutch and US sites.

Inclusion / Exclusion criteria
Inclusion: symptoms indicative of cardiac arrhythmia (or prior arrhythmia diagnosis) with a doctor-prescribed Holter or 12-lead ECG; age ≥22; able to consent; proficient in Dutch or English.
Exclusion: conditions compromising safety/protocol completion; unable to wear the device (allergies, wounds, amputation); unwilling to receive ECG monitoring or sign consent.

Study Centres
Reinier de Graaf Gasthuis, Delft (NL); Mayo Clinic Rochester, MN; Cena Research Institute, Houston, TX

Start time, Duration
May 2025 – September 2026

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.