Data Collection for Pacemaker Recognition Through Capacitive ECG

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 28, 2019

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nikolaus Marx, Univ.-Prof. Dr. med. – RWTH Aachen University

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