Data Collection for Pacemaker Recognition Through Capacitive ECG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2020-02-13

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.

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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.

Conditions

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Pacemaker DDD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients having a pacemaker

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.

Group Type OTHER

Capacitive ECG

Intervention Type DEVICE

Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology.

Interventions

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Capacitive ECG

Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology.

Intervention Type DEVICE

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No