BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)

Not Applicable

Terminated

Interventions: Diagnostic Test: 3-channel Holter ECG recording
Diagnostic Test: 12-channel Holter ECG recording

Brief Summary: Collection of Holter surface ECGs for the development of new sensing and detection algorithms

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
3-channel Holter ECG recording for EPS patient	3-channel Holter ECG recording	Patients participating in an EPS will undergo a 3-channel Holter ECG recording in parallel to the standard 12-channel Holter ECG recording during the EPS followed by an optional 24 h observation period
12-channel Holter ECG recording for non-EPS patients	12-channel Holter ECG recording	Patients scheduled for a follow-up for their heart disease will undergo a 12-channel Holter ECG recording while participating in a Body Motion test followed by a 24 h observation period

Primary Outcome Measures

Name	Time	Method
Number of Successful ECG Recordings Per Condition	24 hours	All ECG recordings were evaluated by an internal board and all patients were allocated to one of 15 groups (covering 14 ECG patterns of interest and one group for "no ECG pattern of interest recorded").

Secondary Outcome Measures

Name	Time	Method

Locations (5): Vivantes-Krankenhaus im Friedrichshain
🇩🇪
Berlin, Germany
Universitätsklinikum Gießen und Marburg GmbH (UKGM)
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Gießen, Germany
Otto-von-Guericke-Universität Magdeburg
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Magdeburg, Germany
Universitätsklinikum Gießen und Marburg GmbH
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Marburg, Germany
Universitätsklinikum Erlangen
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Erlangen, Germany