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ClinicalTrials.gov Identifier: NCT04243070
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.

Condition or disease Intervention/treatment Phase
Heart Diseases Rhythm; Abnormal Diagnostic Test: 3-channel Holter ECG recording Diagnostic Test: 12-channel Holter ECG recording Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Number of successful ECG recordings per condition [ Time Frame: 24 hours ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243070


Contacts
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Contact: Silke Allgaier, Dr. +493068905 ext 0 ecg-library-concept@biotronik.com

Locations
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Germany
Vivantes-Krankenhaus im Friedrichshain Recruiting
Berlin, Germany
Contact: Stephan Kische, Dr. med.         
Universitätsklinikum Erlangen Not yet recruiting
Erlangen, Germany
Contact: Martin Arnold, Dr. med.         
Otto-von-Guericke-Universität Magdeburg Not yet recruiting
Magdeburg, Germany
Contact: Conrad Genz, Dr. med.         
Universitätsklinikum Gießen und Marburg GmbH Not yet recruiting
Marburg, Germany
Contact: Ulrich Luesebrink, Dr. med.         
Sponsors and Collaborators
Biotronik SE & Co. KG
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT04243070    
Other Study ID Numbers: RD023
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biotronik SE & Co. KG:
Holter ECG recording
Additional relevant MeSH terms:
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Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes