Collection of ECG Signals From Various Patient Groups for the Development of Algorithms for Sensing and Detection of Rhythm Anomalies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 89
- Locations
- 5
- Primary Endpoint
- Number of Successful ECG Recordings Per Condition
Study Overview
Brief Summary
Collection of Holter surface ECGs for the development of new sensing and detection algorithms
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: 3-channel Holter ECG recording (Diagnostic Test)
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
Intervention: 12-channel Holter ECG recording (Diagnostic Test)
Outcomes
Primary Outcomes
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").
Secondary Outcomes
No secondary outcomes reported