Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Myant Medical Corp.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Difference in Usable ECG
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions:
- Can the textile sensors provide continuous monitoring and detect arrhythmias?
- Do patients prefer to wear textile sensors instead of the Holter?
Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease.
- •Age above 18
- •Understand and speak English enough to consent and answer the study questionnaire.
- •A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device)
Exclusion Criteria
- •Pregnancy
- •Implanted defibrillator or pacemaker
- •Absence of garment fitting the participant's body
- •Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
- •Severe frailty such that donning or doffing the garment may cause a danger of fall.
- •Sensitive skin
Outcomes
Primary Outcomes
Difference in Usable ECG
Time Frame: Throughout the entire data collection period, that is between 1 and 14 days
The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear
Difference in Heart Rate
Time Frame: Throughout the entire data collection period, that is between 1 and 14 days
The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear
Difference in RR intervals
Time Frame: Throughout the entire data collection period, that is between 1 and 14 days
The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear
Arrhythmic events
Time Frame: Throughout the entire data collection period, that is between 1 and 14 days
The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear
Secondary Outcomes
- Patient's perception(At the end of the study, 1 to 14 days after initiation.)