Electrocardiogram Clinical Validation Study

Atrial Fibrillation Clinical Trial

Official title:

Electrocardiogram Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492554
• Other study ID #: 099-11774
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: May 14, 2018

Study information

• Verified date: November 2020
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: May 14, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• 1-Lead ECG
All participants will record three single-lead ECGs

Device:
• 12-Lead ECG
All participants will simultaneously record three 12-lead ECGs

Locations

Country	Name	City	State
United States	QPS	Miami	Florida
United States	BioClinicia- Orlando	Orlando	Florida
United States	IQVIA	Overland Park	Kansas
United States	Health East	Saint Paul	Minnesota
United States	BioClinica- The Villages	The Villages	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	Iqvia Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Specificity of rhythm classification	1 Day
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	Sensitivity of rhythm classification	1 Day
Secondary	Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference	Number of ECGs that pass a visual overlay	1 Day
Secondary	Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference	Difference in R-wave amplitudes between the software and gold standard reference	1 Day
Secondary	Ease of Use	Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale	1 Day