N/A
N=602
Electrocardiogram Clinical Validation Study
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03492554 ↗Enrolled (actual)
602
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG — 238 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1-Lead ECG (Other); 12-Lead ECG (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Apple Inc.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG |
238 | <0.0001 sig |
| PRIMARY Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG |
236 | <0.0001 sig |
| SECONDARY Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference |
58; 65 | <0.0001 sig |
| SECONDARY Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference |
58; 65 | <0.0001 sig |
| SECONDARY Ease of Use |
2; 1; 4; 2; 14; 16 | — |
Summary
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
Eligibility Criteria
Inclusion Criteria
- Individuals who are 22 years of age and older
- Able to read, understand, and provide written informed consent
- Willing and able to participate in the study procedures as described in the consent
- Have a wrist circumference that fits within the band
- Able to communicate effectively with and follow instructions from the study staff
- For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening
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 (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of 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 electrode attachment sites
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices
- A history of abnormal life-threatening rhythms as determined by the investigator
- Significant tremor that prevents subject from being able to hold still
- Pregnant women: Women who are pregnant at the time of study participation
- For subjects enrolled into the sinus rhythm population, they must not have any diagnosis of AF
Data sourced from ClinicalTrials.gov (NCT03492554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.