Trials Sponsors Conditions Drugs Pricing

Conditions

Arrhythmias, Cardiac Atrial 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

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

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.

Sponsors & Collaborators

Heart Center Leipzig - University Hospital
Othercollaborator
Helios Health Institute GmbH
Otherlead

Study Sites (1)

Andreas Bollmann

Leipzig, 04289, Germany

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

Enrollment

500 participants (actual enrollment reported by the registry).

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

Actual (reported)

Smart Watch iECG for the Detection of Cardiac Arrhythmias

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Patients suspected with Cardiac Arrhythmia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Patients suspected with Cardiac Arrhythmia

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (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