Holter Versus Skiin Garments

NCT ID: NCT05983484

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-02-01

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.

Conditions

Cardiac Arrhythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Skiin 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).

Intervention Type: DEVICE

Other Intervention Names

PocketECG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners in Advanced Cardiac Evaluation

UNKNOWN

Sponsor Role: collaborator

Myant Medical Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaariv Khaykin, MD

Role: PRINCIPAL_INVESTIGATOR

Partners in Advanced Cardiac Evaluation

Locations

Partners in Advanced Cardiac Evaluation (PACE) clinic

Newmarket, Ontario, Canada

Countries

Canada

Other Identifiers

MYANT/PACE - 073-1819-7

Identifier Type: -

Identifier Source: org_study_id