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Insufficient enrollment rates so that proper completion of the study cannot be expected anymore.
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Collection of Holter surface ECGs for the development of new sensing and detection algorithms
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-channel Holter ECG recording | Diagnostic Test | 3-channel Holter ECG recording for patients undergoing an EPS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
(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:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Contzen, Dr. | Biotronik SE & Co. KG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes-Krankenhaus im Friedrichshain | Berlin | Germany | ||||
| Universitätsklinikum Erlangen |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | According to the statistical analysis plan it was pre-specified to report baseline data for the total population only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | 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. | Posted | Number | Successful ECG recordings | 24 hours | Holter ECG recordings | Holter ECG recordings |
|
2 days on average
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac procedure complication | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Project Management | BIOTRONIK SE & Co. KG | +49 30 68905 | 0 | mathias.freudigmann@biotronik.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2019 | Feb 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2022 | Feb 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12-channel Holter ECG recording | Diagnostic Test | 12-channel Holter ECG recording for patients undergoing a routine follow-up |
|
| Erlangen |
| Germany |
| Universitätsklinikum Gießen und Marburg GmbH (UKGM) | Giessen | Germany |
| Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Marburg | Germany |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and 2. Frequent Ventricular Extrasystoles (VES) (incl. Bigeminus) |
| OG002 | Atrioventricular Reentrant Tachycardia (AVRT)/Wolff-Parkinson-White (WPW) Syndrome | 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 |
| OG003 | Atrioventricular Nodal Reentrant Tachycardia (AVNRT) | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Atrioventricular Nodal Reentrant Tachycardia (AVNRT) |
| OG004 | Sinus Tachycardia at Rest | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Sinus Tachycardia at rest |
| OG005 | Atrial Flutter | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Atrial Flutter |
| OG006 | Any Form of Ventricular Tachycardia | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and any form of Ventricular Tachycardia |
| OG007 | Silent/ Paroxysmal/ Persistent/ Permanent Atrial Fibrillation (AF) | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and silent/ paroxysmal/ persistent/ permanent Atrial Fibrillation (AF) |
| OG008 | Brugada Syndrome | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Brugada syndrome |
| OG009 | Long QT Syndrome | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Long QT syndrome |
| OG010 | Right Bundle Branch Block (RBB) | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Right Bundle Branch Block (RBB) |
| OG011 | Left Bundle Branch Block (LBB) | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Left Bundle Branch Block (LBB) |
| OG012 | Myocardial Ischemia/ Acute Myocardial Infarction | Patient either without pacemaker/ICD or with pacemaker/ICD, but without significant atrial and ventricular stimulation and Myocardial Ischemia/ Acute Myocardial Infarction |
| OG013 | Other Abnormal QRS(T) Complex, ST Segment or T-wave Morphology | 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 |
| OG014 | No ECG Pattern of Interest Recorded | Patient with no ECG pattern of interest recorded |
|
|
| 0 |
| 66 |
| 3 |
| 66 |
| 1 |
| 66 |
| EG001 | 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 | 0 | 23 | 0 | 23 | 5 | 23 |
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bone marrow infiltration | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Endometrial disorder | Reproductive system and breast disorders | Systematic Assessment |
|
| Puncture site haematoma | General disorders | Systematic Assessment |
|
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