NCT05045456

Completed

Observational Clinical Investigation of EKG Diagnostic Perfo...

Cardiologs Technologies Source

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Other study identifiers

Sponsor study identifier

AI Watch2

Study Type

observational

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

November 9, 2021

Actual (reported)

Primary Completion

February 23, 2022

Actual (reported)

Study Completion

February 23, 2022

Actual (reported)

Brief Summary

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)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: February 23, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 7, 2021
Actual (reported)
First Posted
September 16, 2021
Actual (reported)
Study Start
November 9, 2021
Actual (reported)
Primary Completion
February 23, 2022
Actual (reported)
Study Completion
February 23, 2022
Actual (reported)

Last Updated: March 3, 2022
Status Verified: March 2022
Last Update Submitted: March 2, 2022

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

Performance of AF detection
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 Outcomes (2)

AW versus AI-AW
1 day
AI-AW versus AI-12lead
1 day

Interventions

Cardiologs PlatformDevice

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

Also known as: Apple Watch

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

You may qualify if:

Patient aged 22 or older, able and willing to participate in the study

Sponsors & Collaborators

Cardiologs Technologies
Industrylead

Study Sites (1)

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Massy, 91300, France

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Laurent Fiorina, Dr
Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

November 9, 2021

Actual (reported)

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Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database

Completed

NCT05686330

Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)

Not ApplicableCompleted

NCT05279833

Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation

Completed

NCT05009797

PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Recruiting

NCT06620575

Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation

Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

February 23, 2022

Actual (reported)

Study Completion

February 23, 2022

Actual (reported)

Last Updated

March 3, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05045456
Data provider: ClinicalTrials.gov
Source updated: 2022-03-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:06 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations