Aino ECG Ambulatory Study

NCT05008601 | Completed

• 1 other identifier: AinoECG_Ambulatory
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation and Flutter

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

  6 months

Interventions

Wrist-word optical heart rate and ECG measurement device DEVICE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Implanted permanent pacemaker
• Inability to give informed consent e.g. due to mental confusion
• Denial

Sponsors & Collaborators

• PulseOn Oy: lead
• TAYS Sydänkeskus Oy: collaborator
• Atostek Oy: collaborator

Study Sites (1)

Tampere Heart Hospital

Tampere, Finland

Location

Related Publications (1)

• Saarinen HJ, Joutsen A, Korpi K, Halkola T, Nurmi M, Hernesniemi J, Vehkaoja A. Wrist-worn device combining PPG and ECG can be reliably used for atrial fibrillation detection in an outpatient setting. Front Cardiovasc Med. 2023 Feb 9;10:1100127. doi: 10.3389/fcvm.2023.1100127. eCollection 2023.

  PMID: 36844740 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jussi Hernesniemi, Docent

  Tampere Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 17, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-08

Locations

FI (1)