Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Electromagnetic Interference Clinical Trial

Official title:

Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02330900
• Other study ID #: 14-245
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2014
• Last updated: January 2, 2015
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: University Hospital, Geneva
• Contact: Haran Burri, MD
• Email: haran.burri[@]hcuge.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Description:

Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Implantation with a wireless-enabled ICD

Exclusion Criteria:

• Age <18yrs

• inability to sign an informed consent

• pacemaker dependancy

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Electromagnetic Interference

Intervention

Other:
• Study group
Exposure to cell phone interference of the ICD

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.	Detection of electromagnetic interference	5-10minutes	No