Aino ECG Ambulatory Study

Arrhythmias, Cardiac Clinical Trial

Official title:

Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008601
• Other study ID #: AinoECG_Ambulatory
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: PulseOn Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device.

During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age: = 18 years

• Suspected or earlier diagnosed episodic cardiac arrhythmia, for example atrial fibrillation or atrial flutter

• Ability to give informed consent

• Volunteering for the study

Exclusion Criteria:

• Implanted permanent pacemaker

• Inability to give informed consent e.g. due to mental confusion

• Denial

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation and Flutter

Intervention

Device:
• Wrist-word optical heart rate and ECG measurement device
Aino ECG: wrist-word optical heart rate and ECG measurement device

Locations

Country	Name	City	State
Finland	Tampere Heart Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
PulseOn Oy	Atostek Oy, TAYS Sydänkeskus Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device		6 months
Primary	Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.		6 months
Primary	Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.		6 months
Secondary	Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype		6 months
Secondary	To obtain feedback regarding the usability of the Aino ECG wrist device	The feedback is obtained with feedback form filled by the study participants. The form includes questions regarding: overall impression on the study device, easiness of noticing and interpret the notifications of the device, comfortability of using the device, easiness of adjusting the tightness of the wrist band, and operation of the intermittent ECG measurements.	6 months