BIO|CONCEPT.ECG-Library

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04243070
• Other study ID #: RD023
• Status: Terminated
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: July 14, 2022

Study information

• Verified date: January 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: July 14, 2022
• Est. primary completion date: July 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Diseases
• Rhythm; Abnormal

Intervention

Diagnostic Test:
• 3-channel Holter ECG recording
3-channel Holter ECG recording for patients undergoing an EPS
• 12-channel Holter ECG recording
12-channel Holter ECG recording for patients undergoing a routine follow-up

Locations

Country	Name	City	State
Germany	Vivantes-Krankenhaus im Friedrichshain	Berlin
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Gießen und Marburg GmbH (UKGM)	Gießen
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg
Germany	Universitätsklinikum Gießen und Marburg GmbH	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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