Clinical trial NCT04243070: BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)
Official title: Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Diseases
Rhythm; Abnormal
Keywords: Holter ECG recording
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

1. 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:
2. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or
3. Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome or
4. Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or
5. Sinus Tachycardia at rest or
6. Atrial Flutter or
7. Any form of Ventricular Tachycardia (VT) or
8. Silent/Paroxysmal/persistent/permanent AF or
9. Brugada syndrome or
10. Long QT syndrome or
11. Right Bundle Branch Block (RBBB) or
12. Left Bundle Branch Block (LBBB) or
13. Myocardial Ischemia/Acute Myocardial Infarction or
14. 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

Primary outcomes:
measure: Number of Successful ECG Recordings Per Condition
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes-Krankenhaus im Friedrichshain
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH (UKGM)
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
Study officials:
affiliation: Biotronik SE & Co. KG
name: Klaus Contzen, Dr.
role: STUDY_CHAIR
References: