Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG (PROCESS)

Mayo Clinic

Status: Completed

Conditions: Healthy

Study type: Observational

Funder types: Other

Identifiers

NCT05450809

21-006770

Details and patient eligibility

About

The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

Full description

1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
2. Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
3. This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years and ≤ 89.
• Able to give verbal consent.
• Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.

Exclusion criteria

• Individuals < 18 and > 89 years of age.
• Unable to given verbal consent.

Trial design

1,000 participants in 1 patient group

Ambulatory, outpatient Mayo Clinic ECG lab patients

Description:

Patients who are undergoing routine clinical evaluation with a 12 lead ECG recording ordered at the Mayo Clinic ECG lab.