ECG App Algorithms Clinical Validation Study | NCT04247581

NCT04247581

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
IQVIA Pty Ltd	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Other	This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening	Device: 1-lead ECG
Cohort 2	Other	This will include subjects with known persistent or permanent AF who are in AF at the time of screening	Device: 1-lead ECG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1-lead ECG	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 Day
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	1 Day

Secondary Outcomes

Measure	Description	Time Frame
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
Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Hope Research Institute		Phoenix	Arizona	85018	United States
Clinical Research of South Florida

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

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.

Posted

Number

percentage of trials

1 Day

Trials

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 5, 2019	Mar 17, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 6, 2020	Mar 17, 2021	SAP_001.pdf

ID	Term
D001281	Atrial Fibrillation
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D001145	Arrhythmias, Cardiac

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004562	Electrocardiography
D005081	Exercise Therapy

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis