NCT02330900

Brief Summary

Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

November 25, 2014

Last Update Submit

May 10, 2016

Conditions

Electromagnetic Interference

Keywords

Implantable cardioverter defibrillatorElectromagnetic interferenceCell phone

Outcome Measures

Primary Outcomes (1)

  • Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.

    Detection of electromagnetic interference

    5-10minutes

Study Arms (1)

Study group

NO INTERVENTION

Evaluation of interference

Other: Study group

Interventions

Study groupOTHER

Exposure to cell phone interference of the ICD

Study group

Eligibility Criteria

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

You may qualify if:

  • Implantation with a wireless-enabled ICD

You may not qualify if:

  • Age \<18yrs
  • inability to sign an informed consent
  • pacemaker dependancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Burri H, Mondouagne Engkolo LP, Dayal N, Etemadi A, Makhlouf AM, Stettler C, Trentaz F. Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators. Europace. 2016 May;18(5):726-31. doi: 10.1093/europace/euv374. Epub 2016 Feb 8.

    PMID: 26857191DERIVED

Study Officials

  • Haran Burri, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 25, 2014

First Posted

January 5, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CH(1)