ECG App Algorithms Clinical Validation Study

NCT ID: NCT04247581

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2020-03-20

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cohort 1

This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening

Group Type: OTHER

1-lead ECG

Intervention Type: 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.

Cohort 2

This will include subjects with known persistent or permanent AF who are in AF at the time of screening

Group Type: OTHER

1-lead ECG

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

12- lead ECG; Exercise

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Apple Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hope Research Institute

Phoenix, Arizona, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

American Health Network of Indiana LLC

Avon, Indiana, United States

Heartland Cardiology

Wichita, Kansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

013

Identifier Type: -

Identifier Source: org_study_id