Aino ECG Ambulatory Study

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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation and Flutter
• Intervention / Treatment: Device: Wrist-word optical heart rate and ECG measurement device

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Tampere Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The source population of the study includes patients referred to a therapeutic evaluation or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to one third) of the subjects may be having on-going atrial fibrillation at the beginning of the measurement and may suffer from persistent or permanent atrial fibrillation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device	6 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype		6 months
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

Collaborators and Investigators

• Sponsor: PulseOn Oy
• Collaborators: TAYS Sydänkeskus Oy; Atostek Oy
• Investigators: Principal Investigator: Jussi Hernesniemi, Docent, Tampere Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: AinoECG_Ambulatory

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No