Data Collection for Pacemaker Recognition Through Capacitive ECG (HSM-cECG)

RWTH Aachen University

Status: Completed

Conditions: Pacemaker DDD

Treatments: Device: Capacitive ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT04163965

18-104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients having a pacemaker

Other group

Description:

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.

Treatment:

Device: Capacitive ECG