Atrial Fibrillation
Conditions
Keywords
Cardiovascular diseases, Heart Diseases, Arrhythmia, Cardiac
Brief summary
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
Interventions
DEVICE1-lead ECG
1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise. Intervention Other: Exercise - All participants will undergo three trials of exercise. Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.
Sponsors
Iqvia Pty Ltd
Apple Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must meet all the following inclusion criteria to be enrolled: 1. Able to read, understand, and provide written informed consent 2. Willing and able to participate in the study procedures as described in the consent form 3. Individuals who are 22 years of age and older at time of screening 4. Able to communicate effectively with and follow instructions from the study staff 5. Have a wrist circumference between 130 mm and 245 mm (Measured at band center on the preferred wrist). 6. Subjects enrolled into Cohort 1 must have no known medical history of AF and in normal sinus rhythm at the time of screening. 7. Subjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AF and be in AF at the time of screening.
Exclusion criteria
* Subjects must meet none of the following criteria to be enrolled: 1. Physical disability that precludes safe and adequate testing 2. Physical or medical impairments that preclude exercise testing such as musculoskeletal back pain, arthritis, leg claudication, etc. 3. Mental impairment as determined by the Investigator 4. Pregnant women at the time of the screening visit. 5. Subjects with any Medical History, Physical exam, vital sign or any other study procedure finding/assessment that in the opinion of the investigator could compromise subject safety during study participation or interfere with the study integrity and/or the accurate assessment of the study objectives. This includes patients with known untreated medical conditions that are considered clinically significant by the Investigator, such as but not limited to significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease. Physical exam limitations include but not limited to open wound(s) on the wrist and forearm where the subject will be wearing the watch. 6. Any history of wrist surgery with scarring in the area of the sensor location on the wrist where the subject will be wearing the watch 7. Vital signs measurement, medical history, or physical exam finding that makes the subject inappropriate for participation according to the Investigator. 8. Tattoos or moles in the area of the sensor location on the wrist where the subject will be wearing the watch. 9. Skin conditions on either wrist that would preclude subject from wearing watch on either wrist. Severe symptomatic (or active) overly dry/injured skin, skin disorders, or allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on wrist and locations where the electrodes will be placed (e.g. chest, forearms, stomach), as determined by the investigator. 10. Known allergy or significant sensitivity to medical adhesives, isopropyl alcohol, or ECG patch 11. Known allergy or sensitivity to fluorocarbon-based synthetic rubber, such as fluoroelastomer bands primarily used in the wrist worn fitness devices. 12. Clinically significant hand tremors as judged by the Investigator. 13. Participation in a previous study that involved a wrist-worn ECG device. 14. Subjects with implanted cardiac devices such as a Pacemaker or an automated Implantable Cardioverter - Defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as Sinus Rhythm or High Heart Rate on a Readable and Classifiable ECG App Strip. | 1 Day | Specificity of sinus rhythm classification |
| Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as AF on a Readable and Classifiable ECG App Strip. | 1 Day | Sensitivity of sinus rhythm classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Trials With Correct Classification of AF at Normal Heart Rates as AF on a Readable and Classifiable ECG App Strip | 1 Day | — |
| Percentage of Trials With Correct Classification of AF at High Heart Rates as AF (High Heart Rate) on a Readable and Classifiable ECG App Strip | 1 Day | — |
| Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as High Heart Rate on a Readable and Classifiable ECG App Strip | 1 Day | — |
| Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement | 1 Day | A pass rating is given when the difference of the R-wave amplitudes (typically the highest peak of one cardiac rhythm cycle) between the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG is \<= 2mm. The R-wave amplitude agreement will be considered equivalent if at least 80% of the largest R-wave amplitudes of the paired waveforms are given a pass rating. |
| Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes | 1 Day | A pass rating is given when the waveforms of the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG appear to overlay to the unaided eye. The morphology of the waveforms will be considered equivalent if at least 80% of the paired waveforms for the first 6 PQRST complexes are given a pass rating. |
| Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as Sinus Rhythm on a Readable and Classifiable ECG App Strip | 1 Day | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions. | 241 |
| Cohort 2 This will include subjects with known persistent or permanent AF who are in AF at the time of screening
1-lead ECG: 1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
Intervention Other: Exercise - All participants will undergo three trials of exercise.
Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions. | 305 |
| Total | 546 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 225 Participants | 259 Participants |
| Age, Categorical Between 18 and 65 years | 207 Participants | 80 Participants | 287 Participants |
| Age, Continuous | 43.1 Years STANDARD_DEVIATION 15.92 | 69.7 Years STANDARD_DEVIATION 9.35 | 58.0 Years STANDARD_DEVIATION 18.32 |
| Race/Ethnicity, Customized Ethnicity: Hispanic or Latino | 99 Participants | 71 Participants | 170 Participants |
| Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino | 142 Participants | 234 Participants | 376 Participants |
| Race/Ethnicity, Customized Race: American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race: Asian | 13 Participants | 1 Participants | 14 Participants |
| Race/Ethnicity, Customized Race: Black or African American | 35 Participants | 4 Participants | 39 Participants |
| Race/Ethnicity, Customized Race: More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race: Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race: Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race: White | 185 Participants | 298 Participants | 483 Participants |
| Region of Enrollment United States | 241 participants | 305 participants | 546 participants |
| Sex: Female, Male Female | 129 Participants | 76 Participants | 205 Participants |
| Sex: Female, Male Male | 112 Participants | 229 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 241 | 0 / 305 |
| other Total, other adverse events | 1 / 241 | 0 / 305 |
| serious Total, serious adverse events | 0 / 241 | 0 / 305 |
Outcome results
Primary
Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as AF on a Readable and Classifiable ECG App Strip.
Sensitivity of sinus rhythm classification
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as AF on a Readable and Classifiable ECG App Strip. | 100 percentage of trials |
| Cohort 2 | Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as AF on a Readable and Classifiable ECG App Strip. | 98.5 percentage of trials |
Primary
Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as Sinus Rhythm or High Heart Rate on a Readable and Classifiable ECG App Strip.
Specificity of sinus rhythm classification
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as Sinus Rhythm or High Heart Rate on a Readable and Classifiable ECG App Strip. | 99.3 percentage of trials |
| Cohort 2 | Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as Sinus Rhythm or High Heart Rate on a Readable and Classifiable ECG App Strip. | 100 percentage of trials |
Secondary
Percentage of Trials With Correct Classification of AF at High Heart Rates as AF (High Heart Rate) on a Readable and Classifiable ECG App Strip
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 2 | Percentage of Trials With Correct Classification of AF at High Heart Rates as AF (High Heart Rate) on a Readable and Classifiable ECG App Strip | 83 percentage of trials |
Secondary
Percentage of Trials With Correct Classification of AF at Normal Heart Rates as AF on a Readable and Classifiable ECG App Strip
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Correct Classification of AF at Normal Heart Rates as AF on a Readable and Classifiable ECG App Strip | 100 percentage of trials |
| Cohort 2 | Percentage of Trials With Correct Classification of AF at Normal Heart Rates as AF on a Readable and Classifiable ECG App Strip | 98.9 percentage of trials |
Secondary
Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as Sinus Rhythm on a Readable and Classifiable ECG App Strip
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as Sinus Rhythm on a Readable and Classifiable ECG App Strip | 98.2 percentage of trials |
| Cohort 2 | Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as Sinus Rhythm on a Readable and Classifiable ECG App Strip | 100 percentage of trials |
Secondary
Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as High Heart Rate on a Readable and Classifiable ECG App Strip
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as High Heart Rate on a Readable and Classifiable ECG App Strip | 90.5 percentage of trials |
| Cohort 2 | Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as High Heart Rate on a Readable and Classifiable ECG App Strip | 100 percentage of trials |
Secondary
Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes
A pass rating is given when the waveforms of the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG appear to overlay to the unaided eye. The morphology of the waveforms will be considered equivalent if at least 80% of the paired waveforms for the first 6 PQRST complexes are given a pass rating.
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes | 100 percentage of trials |
| Cohort 2 | Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes | 100 percentage of trials |
Secondary
Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement
A pass rating is given when the difference of the R-wave amplitudes (typically the highest peak of one cardiac rhythm cycle) between the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG is \<= 2mm. The R-wave amplitude agreement will be considered equivalent if at least 80% of the largest R-wave amplitudes of the paired waveforms are given a pass rating.
Time frame: 1 Day
Population: Subjects in each cohort include up to 2 trial measurements (at rest; after exercise). Overall number of units represents the number of trials rather than number of subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement | 96.4 percentage of trials |
| Cohort 2 | Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement | 97.9 percentage of trials |