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Completed

NCT Number: NCT04163965

Data Collection for Pacemaker Recognition Through Capacitive ECG

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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Key information

Conditions

Pacemaker Ddd

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capacitive ECG

Device

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

Primary outcomes

  1. Sensitivity and Specificity of Paced Rhythm Identification

    Time frame: up to 10 weeks after the data collection is completed for each patient

    Cardiologists are asked to classify the heart-beats as "paced" and "normal" in a blind test of mixed normal and capacitive ECG recordings.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: HSM-cECG

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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