Observational Clinical Investigation of EKG Diagnostic Performance of the Apple Watch Augmented With an AI Algorithm

March 2, 2022 updated by: Cardiologs Technologies

Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ECG recordings by Apple Watch performed simultaneously with a 12D ECG measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. Similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ECG recordings with an Apple Watch during the scheduled routine 12D ECG recording.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Massy, France, 91300
        • Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 participants: patients hospitalized for ablation or cardioversion or in cardiology department or patients having cardiac rhythm consultation and who have consented to participate to the study

Description

Inclusion Criteria:

  • Patient aged 22 or older, able and willing to participate in the study
  • Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who comes for regular rhythmology consultations or hospitalized in cardiology department
  • Patient who has read the information note and has given his or her consent before any procedure related to the study
  • Patient affiliated to social security

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
  • Subject related to the investigator or any other staff member directly involved in the conduct of the study
  • Patient incapable of giving consent, minor or adult patient protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of AF detection
Time Frame: 1 day
Performance of AF detection by an artificial intelligence (AI) solution interpreting ECG collected via Apple Watches (AI-AW), compared to physician's diagnosis from the 12 leads ECG
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AW versus AI-AW
Time Frame: 1 day
Comparison of Apple Watch (AW) and AI-AW AF detection performance
1 day
AI-AW versus AI-12lead
Time Frame: 1 day
Comparison of the performance of AF detection by AI-AW and AI applied to the 12-lead ECG
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiologs Technologies

Investigators

  • Principal Investigator: Laurent Fiorina, Dr, Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI Watch2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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