Cardiac Arrhythmia
Conditions
Keywords
ECG, Wearable, Holter
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.
Interventions
DEVICESkiin Underwear
All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).
Sponsors
Partners in Advanced Cardiac Evaluation
Myant Medical Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Usable ECG | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's perception | At the end of the study, 1 to 14 days after initiation. | A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring). |
Countries
Canada
Outcome results
None listed