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HSM-cECG: Data Collection for Pacemaker Recognition Through Capacitive ECG

Sponsor
RWTH Aachen University (Other)
Overall Status
Completed
CT.gov ID
NCT04163965
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
3
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Capacitive ECG
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Data Collection for Pacemaker Recognition Through Capacitive ECG
Actual Study Start Date :
Nov 13, 2019
Actual Primary Completion Date :
Nov 28, 2019
Actual Study Completion Date :
Feb 13, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Aachen Aachen Germany 52074

Sponsors and Collaborators

  • RWTH Aachen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nikolaus Marx, Univ.-Prof. Dr. med., RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT04163965
Other Study ID Numbers:
  • 18-104
First Posted:
Nov 15, 2019
Last Update Posted:
Mar 11, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 11, 2020