Trial Outcomes & Findings for BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms) (NCT NCT04243070)
NCT ID: NCT04243070
Last Updated: 2025-03-11
Results Overview
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").
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
24 hours
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
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
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
12-channel Holter ECG recording: 12-channel Holter ECG recording for patients undergoing a routine follow-up
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
23
|
|
Overall Study
COMPLETED
|
66
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total
n=89 Participants
According to the statistical analysis plan it was pre-specified to report baseline data for the total population only.
|
|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 17.6 • n=89 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=89 Participants
|
|
Region of Enrollment
Germany
|
89 participants
n=89 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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.
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").
Outcome measures
| Measure |
Patient With Pacemaker/ICD and Vp > 30%
n=89 Holter ECG recordings
Patient with pacemaker/ICD and Ventricular stimulation \> 30 %
|
Frequent Ventricular Extrasystoles (VES) (Incl. Bigeminus)
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and 2. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus)
|
Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) Syndrome
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) syndrome
|
Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Atrioventricular Nodal Reentrant Tachycardia (AVNRT)
|
Sinus Tachycardia at Rest
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Sinus Tachycardia at rest
|
Atrial Flutter
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Atrial Flutter
|
Any Form of Ventricular Tachycardia
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and any form of Ventricular Tachycardia
|
Silent/ Paroxysmal/ Persistent/ Permanent Atrial Fibrillation (AF)
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and silent/ paroxysmal/ persistent/ permanent Atrial Fibrillation (AF)
|
Brugada Syndrome
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Brugada syndrome
|
Long QT Syndrome
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Long QT syndrome
|
Right Bundle Branch Block (RBB)
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Right Bundle Branch Block (RBB)
|
Left Bundle Branch Block (LBB)
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Left Bundle Branch Block (LBB)
|
Myocardial Ischemia/ Acute Myocardial Infarction
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Myocardial Ischemia/ Acute Myocardial Infarction
|
Other Abnormal QRS(T) Complex, ST Segment or T-wave Morphology
n=89 Holter ECG recordings
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and other abnormal QRS(T) complex, ST segment or T-wave morphology
|
No ECG Pattern of Interest Recorded
n=89 Holter ECG recordings
Patient with no ECG pattern of interest recorded
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Successful ECG Recordings Per Condition
|
6 Successful ECG recordings
|
12 Successful ECG recordings
|
4 Successful ECG recordings
|
7 Successful ECG recordings
|
7 Successful ECG recordings
|
8 Successful ECG recordings
|
11 Successful ECG recordings
|
10 Successful ECG recordings
|
3 Successful ECG recordings
|
0 Successful ECG recordings
|
5 Successful ECG recordings
|
5 Successful ECG recordings
|
3 Successful ECG recordings
|
4 Successful ECG recordings
|
4 Successful ECG recordings
|
Adverse Events
3-channel Holter ECG Recording for EPS Patient
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
12-channel Holter ECG Recording for Non-EPS Patients
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3-channel Holter ECG Recording for EPS Patient
n=66 participants at risk
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
3-channel Holter ECG recording: 3-channel Holter ECG recording for patients undergoing an EPS
|
12-channel Holter ECG Recording for Non-EPS Patients
n=23 participants at risk
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
12-channel Holter ECG recording: 12-channel Holter ECG recording for patients undergoing a routine follow-up
|
|---|---|---|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
1.5%
1/66 • Number of events 1 • 2 days on average
|
0.00%
0/23 • 2 days on average
|
|
Cardiac disorders
Pericardial effusion
|
3.0%
2/66 • Number of events 2 • 2 days on average
|
0.00%
0/23 • 2 days on average
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.5%
1/66 • Number of events 1 • 2 days on average
|
0.00%
0/23 • 2 days on average
|
Other adverse events
| Measure |
3-channel Holter ECG Recording for EPS Patient
n=66 participants at risk
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
3-channel Holter ECG recording: 3-channel Holter ECG recording for patients undergoing an EPS
|
12-channel Holter ECG Recording for Non-EPS Patients
n=23 participants at risk
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
12-channel Holter ECG recording: 12-channel Holter ECG recording for patients undergoing a routine follow-up
|
|---|---|---|
|
General disorders
Adverse drug reaction
|
0.00%
0/66 • 2 days on average
|
4.3%
1/23 • Number of events 1 • 2 days on average
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • Number of events 1 • 2 days on average
|
0.00%
0/23 • 2 days on average
|
|
Blood and lymphatic system disorders
Bone marrow infiltration
|
0.00%
0/66 • 2 days on average
|
4.3%
1/23 • Number of events 1 • 2 days on average
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/66 • 2 days on average
|
4.3%
1/23 • Number of events 1 • 2 days on average
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/66 • 2 days on average
|
4.3%
1/23 • Number of events 1 • 2 days on average
|
|
General disorders
Puncture site haematoma
|
0.00%
0/66 • 2 days on average
|
4.3%
1/23 • Number of events 1 • 2 days on average
|
Additional Information
Senior Director Clinical Project Management
BIOTRONIK SE & Co. KG
Phone: +49 30 68905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place