Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Not Applicable

Completed

• Conditions: Electromagnetic Interference
• Interventions: Other: Study group

• Registration Number: NCT02330900
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Implantation with a wireless-enabled ICD

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Study group	Evaluation of interference

Primary Outcome Measures

Name	Time	Method
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.	5-10minutes	Detection of electromagnetic interference

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, GE, Switzerland