Data Collection for Pacemaker Recognition Through Capacitive ECG

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04163965

Acronym

HSM-cECG

Enrollment

Registered

2019-11-15

Start date

2019-11-13

Completion date

2020-02-13

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker DDD

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.

Interventions

DEVICECapacitive ECG

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026