Heart DiseasesNCT04243070

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

A study testing 3-channel Holter ECG recording and 12-channel Holter ECG recording in people with Heart Diseases and Rhythm; Abnormal, run by Biotronik SE & Co. KG at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Collection of Holter surface ECGs for the development of new sensing and detection algorithms Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Diseases, Rhythm; Abnormal
What is being tested?: 3-channel Holter ECG recording and 12-channel Holter ECG recording
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 5 sitesGermany
Study dates: 10 Mar 2020to 14 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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):
Patient with pacemaker/ICD and
Ventricular stimulation > 30 % or
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and at least one of the following:

Show all 19Show fewer

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

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

Other trials in Germany

About this study

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

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

Read the detailed description

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.

Conditions: Heart Diseases, Rhythm; Abnormal
Being tested: 3-channel Holter ECG recording, 12-channel Holter ECG recording
Keywords: Holter ECG recording
Medical subject headings: Heart Diseases, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3-channel Holter ECG recordingDiagnostic test
3-channel Holter ECG recording for patients undergoing an EPS
12-channel Holter ECG recordingDiagnostic test
12-channel Holter ECG recording for patients undergoing a routine follow-up

Study groups in NCT04243070
Study group	Role	What they receive
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 Receives: 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 Receives: Diagnostic Test: 12-channel Holter ECG recording

What is being measured

The primary outcome is the main question the study is designed to answer.

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").
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202014 Jul 2022

First posted27 Jan 2020
Study start10 Mar 2020
Primary completion14 Jul 2022
Study completion14 Jul 2022

Why it stopped: Insufficient enrollment rates so that proper completion of the study cannot be expected anymore.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04243070
Sponsor's protocol ID: RD023
Status last verified: Aug 2024
First submitted: 24 Jan 2020
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies
ClinicalTrials.gov ID: NCT04243070
Acronym / sponsor ID: RD023
Conditions: Heart Diseases, Rhythm; Abnormal
Keywords: Holter ECG recording
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient enrollment rates so that proper completion of the study cannot be expected anymore.
Enrolment: 89 participants (actual)
Lead sponsor: Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
Study start: 10 Mar 2020 (actual)
Primary completion: 14 Jul 2022 (actual)
Study completion: 14 Jul 2022 (actual)
First posted: 27 Jan 2020 (actual)
Results: Posted 11 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3-channel Holter ECG recording for EPS patient	Other	Diagnostic Test: 3-channel Holter ECG recordingPatients 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
12-channel Holter ECG recording for non-EPS patients	Other	Diagnostic Test: 12-channel Holter ECG recordingPatients 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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):
Patient with pacemaker/ICD and
Ventricular stimulation > 30 % or

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3-channel Holter ECG recording3-channel Holter ECG recording for patients undergoing an EPS	Diagnostic test	3-channel Holter ECG recording for EPS patient
12-channel Holter ECG recording12-channel Holter ECG recording for patients undergoing a routine follow-up	Diagnostic test	12-channel Holter ECG recording for non-EPS patients

Primary outcome

Number of Successful ECG Recordings Per Condition
Time frame: 24 hours
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").

Results and safety

Results posted to the registry on 11 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3-channel Holter ECG Recording for EPS Patient	66	66
12-channel Holter ECG Recording for Non-EPS Patients	23	23

Primary outcome: Number of Successful ECG Recordings Per Condition

Time frame: 24 hours. Number. Unit: Successful ECG recordings

Measure	Patient With Pacemaker/ICD and Vp > 30% n = 89	Frequent Ventricular Extrasystoles (VES) (Incl. Bigeminus) n = 89	Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) Syndrome n = 89	Atrioventricular Nodal Reentrant Tachycardia (AVNRT) n = 89	Sinus Tachycardia at Rest n = 89	Atrial Flutter n = 89	Any Form of Ventricular Tachycardia n = 89	Silent/ Paroxysmal/ Persistent/ Permanent Atrial Fibrillation (AF) n = 89	Brugada Syndrome n = 89	Long QT Syndrome n = 89	Right Bundle Branch Block (RBB) n = 89	Left Bundle Branch Block (LBB) n = 89	Myocardial Ischemia/ Acute Myocardial Infarction n = 89	Other Abnormal QRS(T) Complex, ST Segment or T-wave Morphology n = 89	No ECG Pattern of Interest Recorded n = 89
Value	6	12	4	7	7	8	11	10	3	0	5	5	3	4	4

Population analysed: According to the statistical analysis plan it was pre-specified to report the number of successful Holter recordings per ECG pattern for all patients irrespective of the method for Holter recording.

Adverse events

Time frame: 2 days on average. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3-channel Holter ECG Recording for EPS Patient	3 of 66 (4.5%)	1 of 66 (1.5%)	0 of 66
12-channel Holter ECG Recording for Non-EPS Patients	0 of 23 (0%)	5 of 23 (21.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Klaus Contzen, Dr. study chair

Biotronik SE & Co. KG

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 3-channel Holter ECG recording and 12-channel Holter ECG recording in people with Heart Diseases and Rhythm; Abnormal, run by Biotronik SE & Co. KG at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Successful ECG Recordings Per Condition (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.