Data Collection for Pacemaker Recognition Through Capacitive ECG

Study Overview
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Brief Summary
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This study evaluates the signal quality of capacitive ECG (cECG) on pacemaker patients and whether paced rhythms of the pacemaker can be distinguished from the normal beats using cECG signals.

Detailed Description
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In contrast to classical gold-standard ECG, cECG electrodes can sense the electrical activity of the heart even over the clothing of the subject, which allows several applications in out-of-hospital monitoring. The proposed scenarios for cECG revolve around the unobtrusiveness of the measurement with an inferior signal quality to gold standard ECG. The electrical spikes, that come into existence due to the paced rhythms given by a pacemaker, are only visible in ECG signals recorded by adequate medical instrumentation. Whether cECG can deliver enough signal quality to identify the electrical spikes of the paced rhythms needs to be investigated by recording simultaneous normal and capacitive ECG signals.

Official Title
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Data Collection for Pacemaker Recognition Through Capacitive ECG

Conditions
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Pacemaker DDD

Intervention / Treatment
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* Device: Capacitive ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has an implanted pacemaker Subject is under ambulatory or stationary treatment in Uniklinik RWTH Aachen Subject gives his/her written consent Subject is legally and mentally competent to follow the instructions Exclusion Criteria: Subject has other electrically active implants Cardiopulmonary or hemodynamically unstable subjects Subject is placed in a judicial institution Subject is in a dependency or employment relationship with the examiner Subject is legally or mentally unable to give consent for the participation

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients having a pacemaker<br>Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology. Simultaneously standard routine ECG measurements will take place. | Device: Capacitive ECG<br>* Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of Paced Rhythm Identification | Cardiologists are asked to classify the heart-beats as paced and normal in a blind test of mixed normal and capacitive ECG recordings. | up to 10 weeks after the data collection is completed for each patient |