NCT04092985

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

September 16, 2019

Last Update Submit

October 7, 2024

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Keywords

Arrhythmias, CardiacCardiovascular AppRhythm monitoring

Outcome Measures

Primary Outcomes (3)

  • Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results

    Baseline

  • Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG

    Baseline

  • Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results

    Baseline

Secondary Outcomes (4)

  • Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG

    Baseline

  • Proportion of interpretable and non-interpretable iECGs

    Baseline

  • Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: cardiologists interpretation of iECG (index test) and 12-lead ECGs (reference test)

    Baseline

  • Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: ECG App interpretation results (index test) and 12-lead ECGs (reference test)

    Baseline

Study Arms (1)

Patients suspected with Cardiac Arrhythmia

iECG + 12-lead ECG recording in patients suspected with any type of cardiac arrhythmias at the time of recruitment

Device: iECG recording

Interventions

iECG recordingDEVICE

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

Patients suspected with Cardiac Arrhythmia

Eligibility Criteria

Age22 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals who had been admitted to the Department of Electrophysiology, Leipzig Heart Center

You may qualify if:

  • Patients aged≥22 years at the time of eligibility screening will be included.
  • Patients with known cardiac arrhythmias; i.e. AF before and after cardioversion, hemodynamically stable Bradycardias, SVT and VT during EP procedures and implants can also be included

You may not qualify if:

  • \- Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andreas Bollmann

Leipzig, 04289, Germany

Location

Related Publications (1)

  • Behzadi A, Sepehri Shamloo A, Mouratis K, Hindricks G, Arya A, Bollmann A. Feasibility and Reliability of SmartWatch to Obtain 3-Lead Electrocardiogram Recordings. Sensors (Basel). 2020 Sep 7;20(18):5074. doi: 10.3390/s20185074.

    PMID: 32906661RESULT

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas Bollmann, MD, PhD

    Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 17, 2019

Study Start

September 30, 2019

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)