BIO|CONCEPT.ECG-Library

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Rhythm; Abnormal
• Intervention / Treatment: Diagnostic test: 3-channel Holter ECG recording; Diagnostic test: 12-channel Holter ECG recording

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Vivantes-Krankenhaus im Friedrichshain
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Gießen, Germany
    • Universitätsklinikum Gießen und Marburg GmbH (UKGM)
  • Magdeburg, Germany
    • Otto-von-Guericke-Universität Magdeburg
  • Marburg, Germany
    • Universitatsklinikum Gießen und Marburg GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3-channel Holter ECG recording for EPS patient; 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; 3-channel Holter ECG recording for patients undergoing an EPS
Other: 12-channel Holter ECG recording for non-EPS patients; 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; 12-channel Holter ECG recording for patients undergoing a routine follow-up

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): July 14, 2022
• Study Completion (Actual): July 14, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Holter ECG recording
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: RD023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No