BIO|CONCEPT.ECG-Library

Study Overview
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Brief Summary
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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.

Official Title
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Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies

Conditions
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Heart Diseases, Rhythm; Abnormal

Intervention / Treatment
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* Diagnostic Test: 3-channel Holter ECG recording
* Diagnostic Test: 12-channel Holter ECG recording


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3-channel Holter ECG recording for EPS patient<br>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 | Diagnostic Test: 3-channel Holter ECG recording<br>* 3-channel Holter ECG recording for patients undergoing an EPS<br>|
| Other: 12-channel Holter ECG recording for non-EPS patients<br>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 | Diagnostic Test: 12-channel Holter ECG recording<br>* 12-channel Holter ECG recording for patients undergoing a routine follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successful ECG recordings per condition | The number of successful ECG recordings per condition stated in the inclusion criteria, whereat each condition shall be included at least six times and at most ten times; with the exception of 'Any form of Ventricular Tachycardia (VT)' being included at least twelve times or more | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Holter ECG recording