Data Collection for Pacemaker Recognition Through Capacitive ECG

Pacemaker DDD Clinical Trial

— HSM-cECG  

Official title:

Data Collection for Pacemaker Recognition Through Capacitive ECG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163965
• Other study ID #: 18-104
• Status: Completed
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: March 2020
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 13, 2020
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker DDD

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of Paced Rhythm Identification	Cardiologists are asked to classify the heart-beats as "paced" and "normal" in a blind test of mixed normal and capacitive ECG recordings.	up to 10 weeks after the data collection is completed for each patient