Arrythmia, Cardiac, Healthy Adult Participants, Heart Disease
Conditions
Keywords
Electrocardiogram, ECG, EKG, Cardiac diagnostic
Brief summary
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
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).
Interventions
DEVICEeWave Patch
This device is a wearable multi-channel ECG monitoring device for continuous cardiac rhythm tracking.
Sponsors
Wearlinq
ABio Clinical Research Partners
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wear Duration | 7 Days | Days of use until one of the following is reached: patch no longer adheres, signal loss, voluntary removal, or 7 days is achieved |
| Adverse Events | 7 Days | Incidences of self-reported adverse events for the duration of the study |
Countries
United States
Contacts
CONTACTAndrea Brown, MS
CONTACTChris Daniel
STUDY_DIRECTORChris Daniel
WearLinq, Inc.
Outcome results
None listed