NCT03264222

Brief Summary

Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

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

Study Start

First participant enrolled

May 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

June 26, 2017

Last Update Submit

July 31, 2021

Conditions

Electromagnetic Interference

Outcome Measures

Primary Outcomes (1)

  • Electromagnetic interference

    Occurrence of electromagnetic interference

    10 minutes

Study Arms (1)

Exposition to safety screening

OTHER

One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology

Other: Security screening procedure

Interventions

Security screening procedureOTHER

Screening procedure with security device (model QPS 100)

Exposition to safety screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • implantable pacemaker or defibrillator in situ

You may not qualify if:

  • malfunction of implantable pacemaker or defibrillator
  • low battery voltage of implanted cardiac electronic device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

Related Publications (1)

  • Lennerz C, O'Connor MJ, Blazek P, Weigand S, Grebmer C, Reif S, Friedrich L, Reents T, Bourier F, Schunkert H, Deisenhofer I, Kolb C. Modern Security Screening and Electromagnetic Interference With Cardiac Implantable Electronic Devices. J Am Coll Cardiol. 2020 Mar 17;75(10):1238-1239. doi: 10.1016/j.jacc.2020.01.012. No abstract available.

    PMID: 32164898DERIVED

Study Officials

  • Christof Kolb, MD

    Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

August 29, 2017

Study Start

May 1, 2017

Primary Completion

July 12, 2018

Study Completion

October 31, 2018

Last Updated

August 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)