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ID
Source
Brief title
Health condition
Atrial fibrillation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine the sensitivity and specificity of the Wavelet Wristband with Fibricheck algorithm for detection for atrial fibrillation.
Secondary outcome
Determine the accuracy of the Wavelet wristband with Fibricheck algorithm to differentiate atrial flutter and atrial tachycardia from atrial fibrillation.
Background summary
Photoplethysmography (PPG) is frequently used as a method to detect heart rate in commercial wearable sensors based on detection of the pulse rate (being a surrogate for heart rate). The technology is based on small variations in light intensity either by transmission through tissue or reflection. Pulsed blood flow in an artery causes small wave variations that can be detected by the sensors and translated into an estimated heart rate. Photoplethysmography is currently being studied with regard to detection of rhythm disorders, like atrial fibrillation. Heart rate variability and advanced pulse wave form analysis can be used to make algorithms to detect atrial fibrillation.
In this study we will evaluate the accuracy of the Wavelet wristband with Fibricheck algorithm for detection of atrial fibrillation in patients in the setting of an electrical cardioversion.
Patients will wear the device for at least 5 minutes before and after the procedure. The wristband will record the pulse rate and the result be compared to a standard 12-lead ECG.
Study objective
Wavelet wristband with Fribricheck algorithm is accurate to identify atrial fibrillation
Study design
Patients will have a pre-cardioversion PPG recording of 5 minutes done baseline and a 12 lead electrocardiogram will be performed during the recording. The cardioversion will take place and all patients will have a post-cardioversion PPG recording for 5 minuts and a 12 lead ECG. No follow up is required.
Inclusion criteria
• Age > 18 years
• Patients undergoing an elective electrical cardioversion
• Atrial fibrillation or atrial flutter/atrial tahchycardia the day of the procedure.
• Willing and able to provide informed consent
• Willing and able to wear the wristband before and after the cardioversion.
Exclusion criteria
• Urgent cardioversion
• Pregnanacy
• Contraindication to anticoagulation
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7761 |
| Other | Amsterdam UMC : METC VUMC 2018.447 |