NCT04163965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

15 days

First QC Date

November 12, 2019

Last Update Submit

March 10, 2020

Conditions

Pacemaker DDD

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients having a pacemaker

OTHER

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

Interventions

Capacitive ECGDEVICE

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

Patients having a pacemaker

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Aachen

Aachen, 52074, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

November 13, 2019

Primary Completion

November 28, 2019

Study Completion

February 13, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)