arrhythmia, Atrium fibrillation
Conditions
Interventions
From IMDD:A. The CORSANO CardioWatch 287-2 is a rechargeable wearable which can monitor continuous heart rhythm, activity, sleepcycles, SpO2, ECG, EDA and temperature. The main purpose of the CardioWa
GS1: GTINEach CORSANO device has a label indicating the UDI-DI (GTIN).C. The intended patient population in the study where the CardioWatch will be used are patients >
50 year. The patients have no known prior cardiac disease.There are no known contra indications for patients to wear the CardioWatch. It is water resistant and still has accurate PPG signals through d
Sponsors
Corsano Health
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation * Age >= 22 years old * Able to provide informed consent. * Patients with symptoms indicative of cardiac arrhythmias * Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
Exclusion criteria
Exclusion criteria: * Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol; * Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.; * Unable or not willing to receive ambulatory ECG monitoring; * Unable or not willing to sign informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation or atrial flutter (AF) episodes among 30 seconds intervals detected on (1) 24-48 hour ECG Holter or short in-clinic 12-lead ECG, and (2) within the CardioWatch 287-2 photopleythsmography signal, and (3) within the CardioWatch 287-2 single-lead ECG spot-check(s). | — |
Secondary
| Measure | Time frame |
|---|---|
| AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours duration detected by (1) an ECG-holter monitor, and (2) the CardioWatch 287-2 photoplethysmography signal. Additional secondary endpoints include (3) compliance with single-lead ECG alerts and required ECG attempts, together with AF confirmations based on single-lead ECG and the HR compared to reference; (4) assessment of primary outcomes in light of demographic differences based on subgroups for gender; skin color; BMI, and ethnicity; and (5) assessment of primary outcomes in light of other factors impacting device performance including patient activity and signal quality. | — |
Countries
Netherlands, United States
Contacts
Public ContactN. Jaspers
Corsano Health
Outcome results
None listed