Last updated: February 2, 2022
Sponsor: Garmin International
Overall Status: Completed
Phase
N/A
Condition
Arrhythmia
Dysrhythmia
Cardiac Disease
Treatment
N/AClinical Study ID
NCT04842123
ECG-002
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Able to read, understand, and provide written informed consent;
- Willing and able to participate in the study procedures as described in the consentform;
- Individuals who are 22 years of age and older;
- Able to communicate effectively with and follow instructions from the study staff;
- Have a wrist circumference that fits within the device band; and
- For subjects enrolled into the AF population, subjects must have a known diagnosis ofAF and be in AF at the time of screening.
Exclusion
Exclusion Criteria:
- Physical disability that precludes safe and adequate testing;
- Mental impairment resulting in limited ability to cooperate;
- Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD);
- Acute myocardial infarction within 90 days of screening or other cardiovasculardisease that, in the opinion of the Investigator, increases the risk to the subject orrenders data uninterpretable;
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 daysof screening;
- Stroke or transient ischemic attack within 90 days of screening;
- Subjects taking rhythm control drugs;
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,dermatomyositis, or allergic contact dermatitis on both wrists or over electrodeattachment sites, including known allergy or sensitivity to silicone bands primarilyused in wrist-worn fitness devices;
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECGelectrodes;
- A history of abnormal life-threatening rhythms as determined by the Investigator;
- Significant tremor that prevents subject from being able to hold still;
- Women who are pregnant at the time of study participation; and
- Subjects enrolled into the SR population must not have any diagnosis of AF.
Study Design
Total Participants: 568
Study Start date:
March 31, 2021
Estimated Completion Date:
October 04, 2021
Connect with a study center
Hope Research Institute
Phoenix, Arizona 85018
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
HealthEast
Saint Paul, Minnesota 55102
United StatesSite Not Available
Northwell Health North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Northwell Health Lenox Hill Hospital
New York, New York 10075
United StatesSite Not Available
MedStar Health Cardiac Electrophysiology at Fairfax
Fairfax, Virginia 22031
United StatesSite Not Available

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