BIO|CONCEPT.ECG-Library

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Biotronik SE & Co. KG
Updated on 16 February 2024
depression
heart disease
ischemia
myocardial infarction
arrhythmia
infarct
coronary disease
left bundle branch block
holter monitor
ventricular tachycardia
bundle branch block
premature ventricular contractions
sinus tachycardia
atrial flutter
ventricular extrasystoles
long qt syndrome
right bundle branch block

Summary

The aim of the study is to collect data from surface ECGs by using Holter ECG recordings from patients with different forms of diagnosed arrhythmias and/or specific ECG characteristics from heart diseases to support the development of new sensing and detection algorithms for implants.

Details
Condition Arrhythmia, Arrhythmia, Heart disease, Heart disease
Age 18years - 100years
Treatment 3-channel Holter ECG recording, 12-channel Holter ECG recording
Clinical Study IdentifierNCT04243070
SponsorBiotronik SE & Co. KG
Last Modified on16 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is able to understand the nature of the study and willing to provide written informed consent
Patient is willing and able to attend Holter ECG procedure following a visit
History of at least one of the following conditions (established via ECG prior to enrollment)
(A) Patient with pacemaker/ICD and
Ventricular stimulation > 30 % or
(B) Patient either without pacemaker/ICD or with pacemaker/ICD, but without
significant atrial and ventricular stimulation and at least one of the
following
\. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or
\. Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW)
syndrome or
\. Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or
\. Sinus Tachycardia at rest or
\. Atrial Flutter or
\. Any form of Ventricular Tachycardia (VT) or
\. Silent/Paroxysmal/persistent/permanent AF or
\. Brugada syndrome or
\. Long QT syndrome or
\. Right Bundle Branch Block (RBBB) or
\. Left Bundle Branch Block (LBBB) or
\. Myocardial Ischemia/Acute Myocardial Infarction or
\. Other abnormal QRS(T) complex, ST segment or T-wave morphology, i.e. any
other QRS anomaly / ST segment elevation / ST segment Depression / T wave
changes

Exclusion Criteria

Any condition which precludes the patient's ability to comply with the study requirements
Known allergy to patch electrodes
Pregnant or breast feeding
Less than 18 years old
Participation in another interventional clinical investigation
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