Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm

NCT ID: NCT04792905

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2021-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This observational exploratory prospective study 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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiologs

Two Apple Watch recordings (one recording with the watch on the wrist and one on the left side of the abdomen) interpreted by Cardiologs AI done simultaneously with each 12-lead ECG

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Apple Watch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 come for regular rhythmology consultations
* 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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cardiologs Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent Fiorina, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Massy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI Watch

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Apple Heart & Movement Study
NCT04198194 ACTIVE_NOT_RECRUITING
Withings ECG-app Study
NCT05316350 COMPLETED NA