A Usability Study of a Multi-channel ECG Monitoring Device

Purpose

This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.

Conditions

  • Healthy Adult Participants
  • Heart Disease
  • Arrythmia
  • Cardiac

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult >18 years old and able to consent - Capable of using a smartphone app - Willing to shave patch area if needed

Exclusion Criteria

  • Planning to undergo an MRI during the study period - Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies, or any other dermatological conditional that could confound placement or results - Presence of pacemaker, ICD or other implanted electronic devices - Open wounds, lesions or infected or inflamed areas of skin at the placement site (left-center of chest/sternum) - Pregnant or intending to become pregnant during the course of the study

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
7 Day Study 		Participants will receive and apply the WearLinq patch for 7 consecutive days
  • Device: eWave Patch
    This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
Experimental
Extended Use Cohort 		Participants will receive and apply the WearLinq patch for 30 consecutive days
  • Device: eWave Patch
    This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.

Recruiting Locations

ABio Clinical Research Partners
New London, North Carolina 28127
Contact:
Andrea Brown, MS
408-881-2611
wearlinqstudy@abioclinical.com

More Details

Status
Recruiting
Sponsor
Wearlinq

Study Contact

Andrea Brown, MS
408-881-2611
abrown@abioclinical.com

Detailed Description

Once eligibility is determined, participants will receive and apply the WearLinq patch for 7 consecutive days (or until an endpoint is met). A subset of subjects will be asked to participate in an Extended Use Cohort (30 days).