Brief Summary

Single-channel electrocardiograms (lead I of 12-lead surface ECG; 30 seconds) will be collected from subjects/patients at 11 clinical centers in Germany to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms. Heart rhythms of interest are normal sinus rhythm (SR), atrial fibrillation (AF), atrial premature beats (APBs), ventricular premature beats (VPBs), and nonsustained ventricular tachycardia (VT). Per diagnosis, 20,000 ECGs are required, for a total of 100,000 ECGs to be obtained from approximately 10,000 subjects/patients.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

10,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2021

Geographic Reach

1 country

1 active site

Status

unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

November 17, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed

11 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed

Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

November 17, 2020

Last Update Submit

April 5, 2022

Conditions

Sinus Rhythm Atrial Fibrillation Atrial Premature Complexes Ventricular Premature Complexes Ventricular Tachycardia, Nonsustained

Keywords

Automated ECG diagnosis

Outcome Measures

Primary Outcomes (6)

Diagnostic accuracy of AI
Overall diagnostic accuracy of the AI in the diagnosis of normal SR, AF, APBs, VPBs, and nonsustained VT (gold standard: diagnosis by experienced electrophysiologist)
1 year
ECG R-R interval
30-sec mean and standard deviation of R-R intervals
Immediate
ECG QRS-complex duration
Measurement of width/duration of QRS complex; distinction between "narrow" (\<=110ms) and "wide" (\>110ms)
Immediate
ECG QRS-complex fragmentation
Assessment of presence ("Yes") or absence ("No") of QRS-complex fragmentation
Immediate
ECG QTc interval
Calculation of heart rate corrected QT interval (QTc) via Bazett formula from measured QT interval
Immediate
ECG T wave inversion
Assessment of presence ("Yes") or absence ("No") of T wave inversion
Immediate

Secondary Outcomes (3)

ECG P wave
Immediate
ECG PQ interval
Immediate
ECG QT interval
Immediate