Data Collection for Pacemaker Recognition Through Capacitive ECG

Not Applicable

Completed

• Conditions: Pacemaker DDD
• Interventions: Device: Capacitive ECG

• Registration Number: NCT04163965
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study Start: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2019-11-28
• Study Completion: 2020-02-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients having a pacemaker	Capacitive ECG	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Paced Rhythm Identification	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.

Trial Locations

Locations (1)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany