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

Biotronik

Status: Terminated

Conditions: Rhythm; Abnormal; Heart Diseases

Treatments: Diagnostic Test: 12-channel Holter ECG recording; Diagnostic Test: 3-channel Holter ECG recording

Study type: Interventional

Funder types: Industry

Identifiers

NCT04243070

RD023

Details and patient eligibility

About

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

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

3-channel Holter ECG recording for EPS patient

Other group

Description:

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

Treatment:

Diagnostic Test: 3-channel Holter ECG recording

12-channel Holter ECG recording for non-EPS patients

Other group

Description:

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

Treatment:

Diagnostic Test: 12-channel Holter ECG recording