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BIO|CONCEPT.ECG-Library

BIO|CONCEPT.ECG-Library

Recruiting
18 years and older
All
Phase N/A

Overview

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

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

Study details
    Arrhythmia
    Arrhythmia
    Heart disease
    Heart disease

NCT04243070

Biotronik SE & Co. KG

16 February 2024

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