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

NCT04243070 | Terminated Results

• 1 other identifier: RD023
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Heart Diseases; Rhythm; Abnormal

Keywords

Holter ECG recording

Outcome Measures

Primary Outcomes (1)

• Number of Successful ECG Recordings Per Condition

  All ECG recordings were evaluated by an internal board and all patients were allocated to one of 15 groups (covering 14 ECG patterns of interest and one group for "no ECG pattern of interest recorded").

  24 hours

Study Arms (2)

3-channel Holter ECG recording for EPS patient

OTHER

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

12-channel Holter ECG recording for non-EPS patients

OTHER

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

Interventions

3-channel Holter ECG recording DIAGNOSTIC_TEST

3-channel Holter ECG recording for patients undergoing an EPS

3-channel Holter ECG recording for EPS patient

12-channel Holter ECG recording DIAGNOSTIC_TEST

12-channel Holter ECG recording for patients undergoing a routine follow-up

12-channel Holter ECG recording for non-EPS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) or
• Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome or
• Atrioventricular Nodal Reentrant Tachycardia (AVNRT) or
• Sinus Tachycardia at rest or
• Atrial Flutter or
• Any form of Ventricular Tachycardia (VT) or
• Silent/Paroxysmal/persistent/permanent AF or
• Brugada syndrome or
• Long QT syndrome or

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (5)

Vivantes-Krankenhaus im Friedrichshain

Berlin, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH (UKGM)

Giessen, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Marburg, Germany

Location

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director Clinical Project Management
• Organization: BIOTRONIK SE & Co. KG

mathias.freudigmann@biotronik.com

+49 30 68905

Study Officials

• Klaus Contzen, Dr.

  Biotronik SE & Co. KG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 27, 2020
• Study Start: March 10, 2020
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)