search
Back to results

BIO|CONCEPT.ECG-Library

Primary Purpose

Heart Diseases, Rhythm; Abnormal

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
3-channel Holter ECG recording
12-channel Holter ECG recording
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Diseases focused on measuring Holter ECG recording

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

3-channel Holter ECG recording for EPS patient

12-channel Holter ECG recording for non-EPS patients

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 24, 2020
Last Updated
November 6, 2022
Sponsor
Biotronik SE & Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT04243070
Brief Title
BIO|CONCEPT.ECG-Library
Official Title
Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment rates so that proper completion of the study cannot be expected anymore.
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
July 14, 2022 (Actual)
Study Completion Date
July 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Rhythm; Abnormal
Keywords
Holter ECG recording

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-channel Holter ECG recording for EPS patient
Arm Type
Other
Arm 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
Arm Title
12-channel Holter ECG recording for non-EPS patients
Arm Type
Other
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
3-channel Holter ECG recording
Intervention Description
3-channel Holter ECG recording for patients undergoing an EPS
Intervention Type
Diagnostic Test
Intervention Name(s)
12-channel Holter ECG recording
Intervention Description
12-channel Holter ECG recording for patients undergoing a routine follow-up
Primary Outcome Measure Information:
Title
Number of successful ECG recordings per condition
Description
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
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Right Bundle Branch Block (RBBB) or Left Bundle Branch Block (LBBB) or Myocardial Ischemia/Acute Myocardial Infarction or 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
Facility Information:
Facility Name
Vivantes-Krankenhaus im Friedrichshain
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH (UKGM)
City
Gießen
Country
Germany
Facility Name
Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BIO|CONCEPT.ECG-Library

We'll reach out to this number within 24 hrs