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Smart Watch iECG for the Detection of Cardiac Arrhythmias

NCT04092985 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-10-08

No results posted yet for this study

Summary

This study aims to assess the feasibility and reliability of smart watch iECG provided by the Apple Watch/Apple iPhone for the detection of different cardiac arrhythmias. In this study, results from a 12-lead ECG will be set as the gold standard for the arrhythmia diagnosis, and results from the smart watch iECG (Apple watch/Apple iPhone application and Cardiologist's interpretations) as the index tests. The iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application.

Conditions

Interventions

DEVICE

iECG recording

iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Helios Health Institute GmbH

    lead OTHER

Principal Investigators

  • Andreas Bollmann, MD, PhD · Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-07-30
Completion
2021-07-30
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092985 on ClinicalTrials.gov