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| Name | Class |
|---|---|
| Partners in Advanced Cardiac Evaluation | UNKNOWN |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skiin Underwear | Device | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Usable ECG | The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days |
| Difference in Heart Rate | The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days |
| Difference in RR intervals | The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days |
| Arrhythmic events | The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's perception | 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). | At the end of the study, 1 to 14 days after initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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adults with cardiovascular disease and/or risks justifying the need for performing an ECG Holter
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| Name | Affiliation | Role |
|---|---|---|
| Yaariv Khaykin, MD | Partners in Advanced Cardiac Evaluation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Partners in Advanced Cardiac Evaluation (PACE) clinic | Newmarket | Ontario | L3Y 2P6 | Canada |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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